Clinical Research Resume Samples

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EH
E Howe
Elissa
Howe
11976 Dangelo Haven
Houston
TX
+1 (555) 491 1941
11976 Dangelo Haven
Houston
TX
Phone
p +1 (555) 491 1941
Experience Experience
01/2016 present
Los Angeles, CA
Senior Site Clinical Research Associate
Los Angeles, CA
Senior Site Clinical Research Associate
01/2016 present
Los Angeles, CA
Senior Site Clinical Research Associate
01/2016 present
  • Provides leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US)/ region (US) of responsibility
  • In the country/region based, manages activities of clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol
  • May conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCP’s), ICH Guidelines, and AbbVie Standard Operating Procedures (SOP’s) and business processes
  • Conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives
  • In the country/region based, manages the SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
  • Builds and maintains a high performance team of monitoring staff
  • In country based, may provide administrative management oversight to up to 8 Study Leads responsible for conduct of study at local level
04/2013 12/2015
Phoenix, AZ
Manager, Clinical Research
Phoenix, AZ
Manager, Clinical Research
04/2013 12/2015
Phoenix, AZ
Manager, Clinical Research
04/2013 12/2015
  • Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans
  • Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director
  • Plans and manages study site activities and provides ongoing updates of site status to management
  • Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
  • Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
  • Oversees all aspects of human resource management including recruitment and retention of assigned staff and ongoing staff performance evaluations
  • Responsible for managing the development, initiation, functionality, progress and completion of clinical databases used in clinical studies managed in the DCC
05/2007 11/2012
San Francisco, CA
Clinical Research Psychologist
San Francisco, CA
Clinical Research Psychologist
05/2007 11/2012
San Francisco, CA
Clinical Research Psychologist
05/2007 11/2012
  • Prepare budgets for research protocols and obtain research grants by preparing and writing protocol applications
  • Collect and maintain data for ongoing research and academic protocols in the DMH
  • Medical discharge planning
  • Major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy
  • Provides diagnostic and therapeutic procedures (including but not limited to)
  • Psychosocial history taking
  • Retrieve, sort and collect data from hard copy and electronic databases. Collect and maintain data for ongoing research and academic protocols
Education Education
Bachelor’s Degree in Clinical
Bachelor’s Degree in Clinical
University of South Florida
Bachelor’s Degree in Clinical
Skills Skills
  • Excellent knowledge of regulations that apply to clinical studies
  • Able to maintain good relationships with physician and other medical providers
  • Strong negotiating skills
  • Strong leadership skills essential
  • Mentor team members to encourage personal and professional growth
  • Ability to prioritize and manage time efficiently
  • Working knowledge of SOPs/regulations relevant to clinical research
  • Ability to exercise independent judgment
  • Relevant therapeutic area experience desirable
  • Good written and oral communication, interpersonal, analytical, conflict resolution, and problem-solving skills
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1

Clinical Research Data Specialist Lead Resume Examples & Samples

  • Able to practically apply strong knowledge of the federal regulations governing the protection of human subjects e.g. FDA, GCP/ICH guidelines, OHRP and HIPAA regulations
  • Attends and actively participates in all internal and external protocol start up orientations
  • Acts as the primary site contact for the sponsor’s CRA for assigned industry trials
  • Able to practically apply knowledge in research regulations, including the reporting of Serious Adverse Events (SAE) and protocol violations
  • Ensures that collection of clinical data is available to the PI, Sponsor and CRO in a timely manner
  • For in house, NCI sponsored and Cooperative Group studies, interacts with QA Team to ensure accuracy of CRFs prior to submission
  • If required by protocol, contacts patient or family for survival status after patient is taken off treatment; ensures that the Café database status fields are updated until patient death. If delegates to Data Specialist I, will orient to process and oversee
  • Participates in QAMC audits by thoroughly reviewing assigned patient chart and reporting on results
  • Independently prepares for and participates in NCI, FDA, pharmaceutical and other audits for assigned trials, as well as any other trials assigned to the CISO CRA’s Team
  • Has necessary experience and knowledge to assist Study Coordinator with patient work ups
  • Provides assistance and input to the PI for publishing study results when requested
  • When requested, assists with orienting, training and mentoring newly hired Data Specialists I
  • Provides assistance and guidance to Data Specialists I and II in identifying and assessing protocol violations
  • Provides assistance and guidance to Data Specialists I and II in completing protocol required SAE reports
  • Follows CISO SOPs in conduct of work
  • Knowledgeable about and complies with hospital regulations
  • Follows Medical Records rules for using and returning charts and accessing EPF and Affinity (LAC)
  • Attends and participates in required internal and external meetings and conference calls with sponsors
  • Ensures work environment is organized to function efficiently
  • Observes office etiquette, by acting courteously and professionally with fellow staff members
  • Reports off to assigned Data Specialists and Study Coordinator when away from office for reporting SAEs and other duties for coverage
2

Regional Clinical Research Associate Resume Examples & Samples

  • 2+ years of relevant experience
  • Bachelor's Degree in a related field or BSN
  • Previous experience in the Pharmaceutical industry
  • Basic medical and business knowledge
  • Competency in Clinical Research or having demonstrated adequate level of proficiency within the CRA II competency profile
  • Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations
  • Degree in a Scientific or Healthcare discipline
3

Clinical Research Document Specialist Resume Examples & Samples

  • Comfortable working in a fast-paced environment
  • Knowledge of the HIPAA Privacy Rule $
  • Experience negotiating ICF language with research centers and IRBs
4

Clinical Research Data Specialist Resume Examples & Samples

  • BA/BS or similar preferred
  • 1-3 years minimum experience in data collection / management
  • Self-directed, resourceful, highly motivated, and energetic
  • Mission driven, goal-oriented with commitment and passion to emerging field of AYA oncology
  • Ability to work with and influence peers, project teams and management
  • Must be able to work independently and with direction from the Director(s) and Program Managers
  • Basic analytical skills with data analysis, data interpretation, problem solving and recommendations for action
  • Excellent written and verbal communication as well as interpersonal skills
  • Excellent judgment and ability to interpret information
  • Excellent organizational skills and the ability to prioritize critical tasks
  • Ability to convey information to and manage staff with different backgrounds, abilities and communication skill
5

Clinical Research Associate, Taiwan Resume Examples & Samples

  • Location: Taiwan
  • Arranges for the appropriate destruction of clinical supplies
  • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
  • Maintains complete, accurate and timely data and essential documents in systems utilized fortrial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints
  • Follows the corresponding Monitoring Guidelines for each assigned trial
  • Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times
  • Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
  • Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
  • May participate in the HA and IEC/IRB submission and notification processes as required/appropriate
  • Act as an point of contact in site management practices
  • May be assigned as a coach and mentor to a less experienced site manager
  • May contribute to process improvement and training
6

Clinical Research Associate, Lead Resume Examples & Samples

  • Provide leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work
  • Define, assign, coordinate, oversee and assess utilization and productivity of the monitoring team
  • Coordinate and supervise site monitoring assignments and activities
  • Direct and prioritize team efforts and assess overall team progress against study timelines and metrics
  • Develop performance standards for project team
  • Identify and notify appropriate parties of emerging out of scope activities
  • Evaluate impact on resource needs, study processes and related documents
  • Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance
  • Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance
  • Coordinate the development, use and maintenance of study-specific processes, related documents, templates, monitoring and regulatory tools
  • Define site selection and activation
  • Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes
  • Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives
  • Serve as key site management trial-team member to internal and external partners
  • Collaborate with internal and external partners to develop trial-specific tools and processes
  • Provide input regarding the development of the CRF design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports
  • Review and analyze site payments and associated site status against Clinical Operations budget
  • Identify and oversee trial-related training and performance concerns of monitoring team; maintain awareness of level of performance and training needs; provide ongoing input for development of individual training plan
  • Coordinate and oversee trial-specific training for CRAs which may include therapeutic in-service, reference materials, investigator meeting, team monitor training, on-site co-monitoring and training visits
  • Assist with all aspects of performance management including compiling and providing feedback for team members' annual performance evaluations
  • Supervise and manage monitoring trial-team members' adherence to DCRI and sponsor- specific administrative policies with guidance
  • Review and approve trial-related expense reports, timesheets, and time-off requests
  • Assist in the development, implementation and revision of processes, SOPs and standard forms
  • Support the DCRI's mission, department goals and organizational activities
  • Required:4-5 years related clinical research experience, including 3 years directly related CRA experience or clinical trial management experience
  • Prior experience directly managing local and remote team of monitors ***
  • Significant experience being a lead and mentor ***
  • Experience with streamline monitoring on large trials or experience with managing monitoring across multiple projects
  • ID knowledge and/or international experience a plus
  • Experience working on a network of trials a plus (including Device, Drug, Data Mining, Biomarker Discovery, etc...) ***
  • Strong protocol development experience including the ability to provide operational feedback ***
  • Experience working with large budgets and aggressive timelines
  • Excellent writing and speaking skills
  • Strong multitasking skills and managing priorities across changing situations
  • Ability to think "outside the box" is critical ***
  • Track record of setting up efficient operations for monitoring (i.e. trip report review, trip scheduling , etc)
  • Experience developing action plans, identifying, communicating and resolving issues identified during visits
  • Experience resolving performance issues with staff ***
  • Political "saviness" and maturity -experience working with more than 2 sponsors/multi partners
  • Analytical, creative, methodical, and strong data skills
  • Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
  • Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
  • Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research
  • State of North Carolina license may be required.**
7

Clinical Research Operations Specialist Resume Examples & Samples

  • Bachelor’s degree in Clinical Research/Public Health/ Business or related field
  • 2 years’ experience in project management and clinical research projects
  • Experience supervising, training, and/or mentoring new staff or students
  • Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices
  • Familiarity with clinical terminologies
  • Familiarity with FDA regulatory requirements
8

Cancer Clinical Research Business Manager Resume Examples & Samples

  • Master's degree and six years relevant experience or combination of education and relevant experience
  • User knowledge of Microsoft Office Suite
  • Advanced understanding of financial principles
  • Strong analytical skills to review and analyze complex financial information
  • Demonstrated success in performing meticulous, high quality and compliant work
  • Direct experience managing clinical trial budgets and financial activities of a Clinical Trials Office. Experience working in or with industry, and in cancer research is also desired
9

Breast Oncology Clinical Research Associate Resume Examples & Samples

  • Knowledge of the principles of clinical research and federal regulations
  • Familiarity with IRB guidelines and regulations
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
10

Clinical Research Supervisor Resume Examples & Samples

  • Excellent written and verbal communication skills; excellent interpersonal skills
  • Good leadership, diplomacy, judgment, and decision-making skills
  • Ability to manage multiple priorities in a fast-paced, deadline-driven environment
  • Advanced education Ph.D., Masters, or related training in a related field
  • Three to five years of clinical research experience; preferably managing clinical research involving academic and external/private sector stakeholders
  • A demonstrated history of supervising research staff
  • Experience in Expertise with Project Management software and creating Gantt charts Excellent analytical and problem-solving skills
  • Working knowledge of FDA and NIH regulatory requirements
  • Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
11

Director of Clinical Research Operations Resume Examples & Samples

  • Ten years related research experience
  • Five years of supervisory experience
  • Strong organizational, analytical, and problem-solving abilities
  • Ability to work on matters of high sensitivity and confidentiality with both diplomacy and discretion
12

Clinical Research Technician Resume Examples & Samples

  • Maintain inventory of supplies and equipment
  • Ensure specimens are properly logged, handled and stored
  • Operate standard laboratory and research study equipment
  • Follow direction of research staff or others involved in the clinical research project work
  • Strong communication and computer skills
13

Clinical Research Admin / Director Resume Examples & Samples

  • Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities
  • Interact with clinical site personnel about matters concerning compliance and verification of the trial, FDA and CIRB regulatory requirements, contractual requirements, and shipment and receipt of investigational products
  • Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial
  • Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution
  • Serve as a liaison between performance site personnel, the PPI, the NCC, and the NDMC trial management teams to enforce adherence to study protocol, the trial MOPP, and SAE reporting
  • Assist in the development and maintenance of the trial MOPP
  • Attend and assist in preparation of DSMB and Trial Investigator meetings
  • Prepare monthly study update newsletters for participating sites
  • Coordinate regular conference calls of steering, executive, and scientific advisory committees and face-to-face AHA Conference investigator meetings or other national meetings
  • Interface with CIRB liaison regarding site CRIB approvals, annual renewals, and reporting of SAEs
  • Interface with NDMC data manager regarding site and data quality issues
  • Participate in site initiation visits and staff training as deemed necessary for the trial
  • RCC responsibilities include acute care stroke call availability after normal business hours as required
  • Ability to assist with the coordination of research studies in a particular discipline
  • Ability to make independent contributions to projects and studies based on professional training or functional experience
  • Must be able to interact with study sites in a professional manner
  • Can accomplish work under general direction
  • Capable of advising and explaining information to others
  • Ability to manage moderately complex projects
  • Ability to work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals
  • Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence
  • Graduate degree in natural sciences or an equivalent combination education/experience
  • At least ten (10) years of work experience, with a Minimum of three (3) years of experience directly involved with clinical research or similar experience in medical field preferred
  • Proficiency with regulatory guidelines for clinical trials preferred
  • Proven organizational ability and strong attention to detail
  • Demonstrates decision-making and problem-solving skills
  • Excellent time-management skills, communication and interpersonal skills (written and oral), and computer skills including word processing, spreadsheet, and PowerPoint are required
14

Otolaryngology Clinical Research Coordinator Resume Examples & Samples

  • Flexibility and ability to adapt to various situations
  • Possess a level of comfort working with patients and clinicians
  • Develops knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research
  • Develops knowledge of University of Colorado Denver, UCH, and CHCO Policy and Procedures in relation to conducting multiple clinical research trials
  • Develops a working knowledge of study regulations, budgets, and billing processes
  • Knowledge of basic human anatomy, physiology, and medical terminology
  • A bachelor's degree is required
  • Minimum of 1 year clinical research experience
  • Experience with both sponsor and PI initiated studies
  • Strong regulatory knowledge
  • Experience submitting to the Institutional Review Board
  • Familiar with COMIRB policies
  • Experience with data management, queries and reports
  • Experience with statistical analysis
15

Clinical Research Data Coordinator Resume Examples & Samples

  • Associate’s Degree in a related field or two years’ experience in a medical or clinical environment
  • Knowledge of and experience with basic human anatomy, physiology, and medical terminology
  • Experience using Microsoft Office products
  • Research experience, oncology is a plus
16

Clinical Research RN Resume Examples & Samples

  • Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, Infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures
  • May be called upon to perform the following specific tests and procedures: (1) electrocardiogram; (2) blood pressure, pulse, height, weight, and temperature measurements; (3) phlebotomy and specimen processing and shipping; and (4) pulse oximetry
  • Bachelor’s degree in Nursing
  • One (1) or more years of RN experience in a research and/or oncology
17

Senior Associate, Clinical Research Resume Examples & Samples

  • Ensures that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met
  • Collaborates in the conduct of clinical studies from protocol feasibility through study report generation and sign-off; Ensures that protocol as well as protocol amendments (if applicable) are prepared
  • Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials, etc
  • Writes Clinical Study Reports (CSRs), if needed; Ensures review and approval of CSRs ; Ensures that the monitoring plan is prepared, reviewed and approved
  • Ensures timely review and approval of monitoring visit reports (May perform site (co)-monitoring when needed)
  • Serves as the primary point of contact with Investigators and J&J Study Team
  • Manages study timelines including key milestones
  • Coordinates the processes of Due diligence, site contracting and purchase order preparation as well as invoice tracking
  • Coordinates product and label requests for clinical studies
  • Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP); Approves the IIP prior to authorizing the initial product shipment
  • Ensures investigational product has been approved, labelled, shipped, accepted and returned appropriately; Ensures accountability of Investigational Product at sites
  • Ensures management of retain samples; Ensures set-up and maintenance of electronic trial master files including periodic reviews
  • Ensures input and updating of study status into the global tracking system
  • Participates in the generation of corrective and preventative action plans to address issues and deviations
  • Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately
  • A minimum of a Bachelors’ degree is required, preferably in science, engineering, medicine or related field
  • A minimum of 4 years of experience in the conduct of clinical studies or equivalent is required
  • Previous experience with clinical study management is preferred
  • Experience with ICH/GCP guidelines is required
  • This position may require up to 10% of domestic and international travel.Clinical Data Management
18

Clinical Research Financial Analyst Resume Examples & Samples

  • Prepare a comprehensive quarterly clinical trial financial report and present the report to disease center leaders and administrators
  • Review and develop new financial reporting metrics
  • Assist in all new clinical research staffing decisions based upon financial analysis review
  • Maintain a database of existing clinical trials with payment schedules, dollars received and dollars outstanding
  • Prepare invoices as required by various study sponsors and manage collection of all outstanding receivables including milestone grid management
  • Work with and assist Principal Investigators, administrators, and study teams with the allocation of personnel costs during the quarterly clinical trial offset process
  • Work closely with Research Accounting to maintain and enhance clinical trial accounting policies and procedures
  • Work with Research Accounting and study teams to review and monitor appropriate expenses against budget
  • Serve as a resource to study teams, investigators, and institute departments in clinical research financial matters
  • Bachelor's Degree in Business or related field
  • 0-3 years direct experience or equivalent work experience. Previous clinical research experience preferred
  • Excellent communication skills and organizational abilities are essential
  • Knowledge of computer applications (Excel, Word, Access) is essential
  • Visa sponsorship is not available for this position
19

Clinical Research Auditor Resume Examples & Samples

  • Perform a minimum of 24 audits of DF/HCC clinical trials annually
  • Schedule approximately 2 audits a month with the appropriate research study teams at DFCI, MGH, BWH, BIDMC, BCH, their Affiliates and at external sites engaged in multi-center research
  • Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies
  • Conduct pharmacy and regulatory reviews for the selected protocol
  • Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc
  • Summarize and present audit findings to the Overall Principle Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview
  • Train investigators and study staff in documentation of clinical trial activity, protocol compliance and regulatory requirements
  • Analyze audit findings to appropriately assign major or minor violations, rating the audit and drafting a Final Audit Report for review and approval by the Data & Safety Monitoring Manager
  • Present audit findings to the Audit Committee for final evaluation
  • Document audit findings and outcomes in appropriate repositories
  • May perform special audits upon request (mock audits, Office for Humans Research Studies (OHRS) file reviews, IRB, Affiliate site audits, etc.) or may perform special projects at the request of the ODQ Director or Data & Safety Monitoring Manager
  • Compose “Audit Alerts” to disseminate trends in audit findings across DF/HCC institutions via the research listserv (CRA II)
  • Participate in training sessions regarding the DF/HCC Audit Program (preparing and/or presenting) (CRA II)
  • Provide support for the maintenance of the DF/HCC Clinical Trial Audit Manual, DF/HCC Standard Operating Procedures (SOPs) pertinent to clinical trial auditing and the audit database (CRA III)
  • Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered by the clinical research auditors across the DF/HCC institutions (CRA III)
  • Identify needed DF/HCC system changes within DF/HCC through the extrapolation of the audit findings (CRA III)
  • Provide guidance and mentoring to junior staff through co-auditing during initial training of new hires and act as a subject area expert to junior peers (CRA III)
  • Bachelor’s degree in a scientific field is required at all CRA levels
  • 1-2 years clinical research auditing or monitoring experience, oncology research preferred (CRA II)
  • 3-5 years clinical research auditing or monitoring experience, oncology research preferred (CRA III)
  • Certified Clinical Research Profession (CCRP) from an approved accrediting organization (CRA III)
20

Ubc-lead Clinical Research Associate Resume Examples & Samples

  • Thorough knowledge of sponsor specific project requirements, protocol and timelines
  • Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines
  • Maintains at least one active site per study assignment
  • Assists with project specific training
  • Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks
  • Maintains Q&A log for site and monitoring issues
  • Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
  • Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
  • Attends client and project team meetings – assists with preparation, content and leading of meetings as required
  • Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics
  • Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction
  • Coordinates EDC data entry, if applicable, and DCF resolution
  • Coordinates site assignments in conjunction with Project Manager and Functional Manager; assists with other project specific tasks as delegated by Project Manager
  • Consistently completes on site monitoring in accordance with project specific timelines
  • Attends project team meetings, departmental meetings and 1:1 with manager a minimum of monthly; responsible for content discussed during these meetings
  • Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File with minimal corrections required
  • Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
  • Consistently completes Call Log or Telephone Contact Report detailing communication with sites in a timely manner
  • Maintains regular contact with assigned sites per protocol
  • Consistently completes expense reports within UBC timelines and guidelines
  • Assists PM and management team by being an AIM leader
  • A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
  • I = Instruct how to conduct visit, report/letter writing and manage issues and actions
  • M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
  • Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.)
  • Includes: Clinical Management Plan, Trip Report and Letter Templates, CRF Transmittal Form, Monitoring Worksheet, input for Monitoring Plan
  • Bachelor’s degree – Life Science preferred or equivalent industry and monitoring. Must have Complex Cardiovascular experience
  • Displays leadership, organizational and interpersonal skills
  • Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable)
  • Up to 50% travel
21

Clinical Research Associate Administrator Resume Examples & Samples

  • Manage data according to prescribed standards and transcribe data in case report or data forms
  • Prepare documents for statistical analysis and descriptive data
  • Follow-up with study subjects in accordance with research protocol(s)
  • Ensure compliance with subject consenting and reporting of adverse events and side effects
  • Adhere to legal, professional, and ethical codes of conduct with respect to confidentiality and privacy
  • Ensure that all research efforts are in compliance with Federal, agency, and IRB-specific requirements and regulations
  • Schedule and maintain calendar of data collections, appointments, and updates
22

Clinical Research Associate Positions Resume Examples & Samples

  • A minimum of two years’ experience coordinating research protocols (four years preferred) as a certified research coordinator
  • A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification will be given preference
  • Understanding of AAALAC and USDA regulations regarding animal subjects research
  • A minimum of two years’ experience coordinating research protocols
  • Clinical competence in application of professional nursing theory, practice, and skills for the care of patients
23

Clinical Research & Data Quality Coordinator Resume Examples & Samples

  • Design and develop complex models used for health care data analysis and data mining and for complex health care data relationships to improve data collection activities, data analysis, monitor contractor performance, and member health care outcomes as they relate to Quality Improvement
  • Support the E.H.R. Incentive Program with complex data analyses, including risk assessment and random audit selections, data analysis for federal report purposes and validation of provider and program data
  • Assist internal and external customers with data analysis and data relationships
  • Communicate among AHCCCS divisions and health plan administration for the purpose of identifying, resolving and monitoring data anomalies and general data relationship issues
  • Attend internal and external meetings to answer questions, provide recommendations and participate in problem solving and decision making related to encounter data submissions, processing, analysis and health outcomes
  • Interpret various administrative rules, policies and procedures pertaining to encounter and CQM data
  • Significant experience in PC programming and common software tool usage including but not limited to SPSS, Microsoft Access and Excel, within the context of health care industry
  • Demonstrated experience in statistical or analytical theories and techniques and data-mining skills; superior mathematical skills
  • Proficient understanding of methodology requirements including but limited to HEDIS and CMS Core Measurement sets, as well as extensive understanding of data validation methods
  • Strong ability to effectively lead and/or facilitate a team of professionals from within and/or outside the agency
  • Demonstrated knowledge of State and Federal Policies and Procedures governing Title XIX, Title XXI, Managed Care, Long Term Care, Individuals with Special Health Care Needs, Behavioral Health and Tribal health care entities
  • Advanced degree in biostatistics, statistics, epidemiology, business, health administration or related field
24

Clinical Research Associate, West Coast Resume Examples & Samples

  • Moderate clinical research and independent field monitoring experience
  • Thorough understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an intermediate understanding and application of applicable therapeutic standards
  • Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail
  • Effective command of written and spoken local language, if not English, as well as English
  • Must have valid, current driver's license and ability to secure corporate credit card
  • ACRP CCRA or equivalent certification/credentials strongly preferred
25

Senior Specialist, Clinical Research Resume Examples & Samples

  • Able to function as a subject matter expert (SME) on medical device products
  • Assist in the preparation of study start up activities with a high degree of skill and knowledge. Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled
  • Assist in the preparation of and critically review relevant portions of regulatory submissions for local and government regulatory bodies
  • Participate as a key member to provide analysis in internal protocol compliance meetings, and independent safety review meetings (e.g., DSMB, Medical Monitor, and Clinical Events Committee and protocol deviation meetings)
  • Collaborate with other Clinical Research Associates and project teams to ensure that trials are conducted and maintained in a standardized way
  • Extensive site management experience
  • Ability to communicate and relate well with key opinion leaders and clinical personnel
  • Effective written, verbal and presentation skills
  • Able to build constructive and effective relationships using diplomacy and tact
  • Able to identify problems and root causes while proposing potential solutions
  • Strongly motivated, is able to achieve work goals, and executes through appropriate channels
26

Clinical Research Monitor Report Reviewer Resume Examples & Samples

  • Bachelor’s Degree with 2+ years clinical research experience required
  • Advanced Degree with 0+ years clinical research experience required
  • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel) required
  • Previous experience in clinical monitoring preferred
  • Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, etc.) preferred
27

Clinical Research Monitor Resume Examples & Samples

  • Bachelor’s Degree in life sciences, health related disciplines or nursing
  • 2-3 years Clinical Research experience (preferably with Clinical Monitoring experience)
  • Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Greece
  • Experience with Ethic Submissions & coordination
  • Flexibility in terms of (inter)national travel (up to 80%)
  • Possess a working knowledge of disease state and investigational product
28

Prin Clinical Research Program Resume Examples & Samples

  • Bachelor’s degree and 7+ years of project management experience OR
  • Master's degree and 5+ years of project management experience OR
  • Doctorate and 3+ years of project management experience OR
  • M.D., *D.V.M. (*Board Certified)
  • Expert in MS Project (or similar scheduling software) and Excel skills
  • Medical device or regulated industry experience
  • PMP certification
  • Perform work without appreciable direction. Exercises considerable latitude in determining objectives and approaches to
29

Cra-senior Site Clinical Research Associate Resume Examples & Samples

  • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol in an off-site and affiliate based capacity
  • Conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes
  • May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues)
  • May train and provide guidance to junior staff. Responsible for compliance with applicable Corporate and Divisional Policies and procedures
  • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
  • Reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/ COM/ Sr. COM as appropriate, as defined in the study monitoring plan
  • Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline by enhancing the enrollment schedule of clinical investigative sites
  • May act as back-up or secondary reviewer for other countries as required
  • Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs
  • Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up
  • Employs good financial management to conserve costs of departmental operation and controls travel expenses, with guidance from Senior ACOM/ COM/ Sr. COM as appropriate
  • Identifies, evaluates and recommends new/potential investigators/sites on an on-going basis.( Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.)
  • Participates in special projects/work groups
30

Senior Site Clinical Research Associate Resume Examples & Samples

  • Builds and maintains a high performance team of monitoring staff
  • Provides input to forcast resource requirements for assigned clinical studies in the country(ies) responsible for
  • Advises on pre-audit activities for btoh PV and GCP requirements
  • Ensures audit and inspection readiness in clinical sites within country(ies)/region(s) of responsibility
  • Ensures study-related parameters are tracked as appropriate
  • In country based, might administer budget for salary and operating expenses and might review and approve expenditures to achieve cost effective operations
  • Candidate should be located in Phoenix, AZ
  • Minimum of 6 years clinical research experience, at least 3 years of experience in clinical site monitoring
  • Experience monitoring Immunology
31

Site Clinical Research Associate Resume Examples & Samples

  • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity
  • The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites
  • Bachelor’s Degree required; medical/science/nursing background is preferred
32

Senior Site Clinical Research Associate Resume Examples & Samples

  • Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to: Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs. Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
  • Facilitates Quality Assurance Audit processes as indicated
  • Reviews monitoring visit reports for assigned CRA’s
  • Reports monitoring activities and study site conduct accurately and completely
  • May provide input relative to performance review and development opportunities
  • Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable
  • May coordinate local SCRA team working on the same projects, when applicable
  • Manages investigator payments as per executed contract obligations
  • Negotiates investigator/ hospital agreements with stakeholders
  • Participates in and/or presents at departmental and other functional meetings as needed, including Site Management & Monitoring meetings
  • Maintains appropriate communication with relevant functional areas
33

Clinical Research Medical Director Neuroscience Resume Examples & Samples

  • Three (3) or more years of clinical research experience
  • Strong background in neurodegeneration/neurobehavior
  • Experience on partnered programs
  • Experience and knowledge in designing, conducting and analyzing Phase 2 and/or 3 clinical trials in AD
  • Familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements, particularly for AD
  • Demonstrated ability as a medical expert in a complex matrix environment
34

Head Clinical Research IT Resume Examples & Samples

  • Ability to build strong strategic relationships with key scientific leaders of clinical research
  • Demonstrated ability to get things done in a highly matrixed IT organization
  • Domain expertise in clinical research, including a working knowledge of the scientific disciplines of clinical science, clinical biomarkers, pharmacology, biostatistics and bioinformatics, and how they combine to drive clinical research
  • PhD/ MS in Life Sciences or a related discipline preferred
  • Strong domain expertise in the application of IT to Clinical Research is essential, including a deep understanding of clinical development scientific processes and how they are supported by IT tools and systems
  • 10+ years experience in leadership roles in pharmaceutical R&D IT, and/or clinical development and/or Bioinformatics
  • Ability to lead the analysis of complex and ambiguous business needs, and integrate those into compelling and actionable strategic plans
  • Demonstrated track record of delivering high-value capability projects in an R&D environment
  • Seasoned line management skills, with a particular emphasis on energizing and developing the existing team of effective and experienced technical specialists
  • Ability to create and support a dynamic culture of innovation and continuous improvement in line reports and in the matrix
  • Excellent collaboration and communication skills, with the versatility to build strong partnerships with technical leaders and also become trusted advisers to senior executives
  • This individual will be recognized across BMS R&D as the key leader for Clinical Research IT, and recognized internally and externally as a thought-leader in this field
  • 1601817
35

Clinical Research Associate, Anemia Resume Examples & Samples

  • Assist with clinical data review
  • Interact with CRO and monitor trip report review
  • Assists in tracking and updating study timelines
36

Director of Clinical Research Resume Examples & Samples

  • The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide
  • The successful candidate will have oversight for ongoing and planned product trials within the oncology therapeutic area
  • The Clinical Research MD will report to a more senior member of the oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
  • Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
  • Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans
  • Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
  • Coordinates the collection and analysis of clinical data for internal analysis and review
  • Develops manuscripts for publication in peer-reviewed journals
  • Will be part of a team responsible for defending the clinical development program before regulatory authorities
  • Serves as a scientific and clinical resource within Gilead Clinical Research
37

Clinical Research Associate, Novosibirsk Resume Examples & Samples

  • You hold a Medical Academy degree, nature science or any relevant education
  • 2 years of experience as a CRA in international pharmaceutical company or Clinical Research Organisation
  • You have the ability to analyze data; good presentation, communication skills
  • You are mobile, flexible and result-oriented with a ‘can-do’ attitude
  • Good command of Russian and English oral and written would be a great advantage
38

Clinical Research Psychologist Resume Examples & Samples

  • Execute all appropriate Investigator responsibilities on assigned projects
  • Serve as a Primary and Sub-Investigator on research protocols
  • Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure efficient and compliant clinical operation
  • Assist with the psychological and clinical oversight of all aspects of function and work performed
  • Assist with training and input on performance assessments for clinical operations personnel
  • Work directly with clinical operations personnel in diagnostic assessment of trial subjects, psychiatric histories, and evaluation of inclusion/exclusion criteria for study participants
  • Participate in on-call and general psychiatric coverage schedules
  • Liaise with sponsors on study conduct and study progression as requested
  • Provide psychological consultation as required or requested by the client/sponsor or the clinical staff
  • Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency
  • Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested
  • Establish working relationships with client representatives, promoting confidence and reliability regarding the clinical operations
  • Represent California Clinical Trials Medical to clients in a positive and professional manner
  • Provide support for marketing activities as requested
  • Liaise with physician staff of Glendale Adventist, Brotman MC and local/regional medical consultants as necessary
  • Participate in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies
  • Participate in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
  • Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed
  • Ensure that all established timelines relating to areas of responsibility and assigned projects are met
  • Ensure that the quality standard of clinical work product is met
  • Perform other duties as assigned by immediate supervisor
  • Detailed oriented with the ability to work in a fast paced environment
  • English
  • Clinical practice experience of at least two years is preferred
  • Clinical or pharmaceutical research experience desirable
  • Ability to obtain and maintain an unrestricted license to practice psychological services in the state of California
  • Knowledge of the FDA regulated drug development process is helpful
39

Field Clinical Research Associate Resume Examples & Samples

  • Act as the liaison between the in house Seattle Genetics team, the CRO, vendors, and multiple clinical sites. Maintain close contact with sites by telephone, correspondence, and on-site visits
  • Apply the applicable SOPs, Clinical Monitoring Plan, Research Specimen Manual and CRF Completion Guidelines as indicated
  • Identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with and track start up activities including essential document review and collection, and facilitating Ethics Committee, other committee, and budget/contract review and approval process
  • Perform Site Initiation Visits. Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures and CFR, and GCP/ICH Guidelines
  • Perform Interim Monitoring Visits
  • Perform drug accountability and ensure adequate drug supply
  • Review and authorize research specimen sample shipments to central lab, as applicable
  • Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements
  • Coordinate supply of clinical supplies to the site
  • Ensure site regulatory file is complete and accurate
  • Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance
  • Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan
  • Ensure clinical trial site training records are current and maintained as required
  • May assist in the preparation and follow-up of on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
  • Assist Data Management as required
  • Complete routine administrative tasks in a timely manner
  • Attend staff meetings and trainings as required
  • Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 3 years of relevant clinical monitoring experience
  • Excellent organizational, interpersonal, verbal, and written communication skills, (including experience in making presentations),
  • Demonstrate ability to discuss scientific, medical and therapeutic area information
  • Strong working knowledge of CFR and GCP/ICH requirements
  • Flexibility towards work assignments, new learning and travel. Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
  • IT literate with a strong working knowledge of PC functions and recent experience with Microsoft based applications, Electronic Data Capture Systems, and CTMS, Impact or like system. Experience in oncology preferred, and monitoring complicated trials
40

Lead Clinical Research Associate Temp Resume Examples & Samples

  • Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned
  • Responsible for the oversight and management of the assigned CRA team
  • Act as a mentor to CRAs and provides on-site training as necessary
  • As defined by the study project needs, recruits, qualifies, initiates, monitors, and manages clinical trial centers through all phases of clinical development (Phase I – IV)
  • Serves as liaison between project management team, field sites, investigators, study coordinators, pharmacists, and staff members
  • Develop and participate in CRA project-specific training
  • Contributes to the preparation of IND and other regulatory documents and submissions
  • Conducts trip report review for assigned projects as well as tracks visit/trip report metrics and summarize/report to teams
  • Tracks utilization of visits against the budget in conjunction with the study Project Manager
  • Manages data collection process and responds to questions received from clinical site regarding the protocol and any other study related issues
  • As defined by the study project needs, monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation. Ensures resolution of data queries
  • Assists with the development and negotiation of study budgets for clinical trial centers
  • Assists in the development of clinical protocols, amendments, informed consents, CRF/ source document design, monitoring plan, site instruction manuals, protocol specific training documentation, administrative letters, and other project related documents
  • Assists with the overall management of the project Trial Master File
  • Tracks study enrollment, data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
  • Assists in providing data to prepare sections of the annual and final clinical study reports and clinical sections of regulatory filings
  • A Bachelor’s degree in clinical development, life science or a related field is required
  • Approximately 5-7 years of combined Lead CRA and site monitoring experience in the pharmaceutical or biotech industry required
  • Knowledge of regulatory guidelines including GCP, ICH, CFR etc
  • Excellent prior experience in all aspects of the clinical trial process
  • Must be Proficient in MS Office
  • Prior experience with MS Project desired
  • Experience in CTMS
  • Excellent organizational and communication skills are required
  • Must have the ability to prioritize multiple tasks and complete projects within established deadlines
41

Senior Representative, Clinical Research Resume Examples & Samples

  • Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Code of Federal Regulations (CFR) and Edwards requirements
  • Assist with query management and resolution as needed
  • Maintain effective relationships with external advisors, clinical investigators, vendors, and applicable research staff
  • Participate in work streams and or process improvement initiatives (e.g., RACI)
  • Bachelor’s degree in a related field is preferred
  • Minimum of 1 year of previous work experience working with regulatory documentation for clinical studies is required
  • Proven expertise in MS Office, Adobe, and ability to operate general office machinery
  • Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master file) preferred
  • Excellent written and verbal communication skills and interpersonal relationship skills
  • Strong problem-solving and critical thinking skills
  • Knowledge and understanding of international and domestic medical device regulatory guidelines relevant to clinical protocols
  • Ability to manage confidential information with discretion
  • Ability to interact professionally with all levels of the organization
  • Must be able to work in a team environment
42

Manager, Clinical Research Resume Examples & Samples

  • 1) Collaborate with Global Study Teams and CRO partners to ensure timely, accurate feedback throughout the conduct of the trial
  • Primary point of contact to support planning and execution of Celgene-sponsored clinical trials (phase’s I-IV)
  • Responsible for project leadership and site relationship management of pre-defined Clinical Trial Partner sites to support optimization of key processes and to ensure critical trial milestones/timelines are being met
  • Have a comprehensive overview of all Celgene sponsored clinical study activities in Canada
  • Support the Feasibility process of clinical programs and studies in collaboration with Global Clinical Research Development Operations and CRO partners, as appropriate
  • Scientific/healthcare related degree
  • Relevant therapeutic area experience desirable
  • Excellent knowledge of regulations that apply to clinical studies
  • Strong leadership skills essential
  • Ability to prioritize and manage time efficiently
  • Financial and business awareness
43

Clinical Research Admin Resume Examples & Samples

  • Ensuring successful startup of the study at all clinical sites under the leadership of the principal investigator
  • Managing, coordinating, planning and evaluating research projects or a multi-site research program for the University of Cincinnati, College of Medicine, Department of Psychiatry and Behavioral Neurosciences
  • Managing and mentoring Clinical Research staff positions
  • Ability to serve as a PI on own research project
  • 10 years of relevant experience
  • Graduate degree in health related field or equivalent experience
44

Oncology Clinical Research Associate Resume Examples & Samples

  • Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
  • Educated to degree level (biological science, pharmacy or other health related discipline)
  • Strong working knowledge of EDC systems, IVRS and CTMS
45

Lead Marketing Coordinator Clinical Research Resume Examples & Samples

  • Develop long-term marketing and recruitment strategies to meet ambitious enrollment goals; strategies should include mass marketing, community outreach and engagement, and social media
  • Establish connections both within and outside the University to build collaborative recruitment relationships
  • Manage vendor connections and financial planning for strategies
  • Ad design
  • Manage a team of community engagement specialists/recruiters to ensure the successful enrollment in the project
  • Hiring and supervising staff, conducting performance reviews, and ensuring staff are appropriately trained
  • Assigns studies and tasks to staff. Ensure staff workloads are appropriate and being performed accurately
  • Manage personnel and performance problems appropriately and swiftly
  • Clinical Research recruitment experience, and/or experience working in an academic medical center or large health system strongly
  • Experience with marketing, advertising, and/or recruitment for clinical trials
  • One year of prior experience supervising, or as a manager of direct reports responsible for hiring decisions and performance reviews
  • Experience in a leadership role, as well as experience mentoring and training junior staff
  • Excellent public relations skills
  • Ability to navigate complex systems and organizational structures
  • Demonstrated understanding of program recruitment and/or ability to be resourceful and tactical in solving recruitment challenges
  • The ability to work effectively with a wide range of individuals and groups at all levels of authority
  • A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail is also required
  • Knowledge of IRB requirements for recruitment desirable
  • Demonstrated excellent organizational skills
  • Ability to direct the work of others, for jobs requiring supervision
46

Clinical Research Associate HVT Germany Resume Examples & Samples

  • Medical field degree in nursing
  • Good English and German (written & spoken)
  • Computer skills – Microsoft Office (Word, Excel, Access, Powerpoint), Internet
  • Familiarity with hospital environment
  • Good communication and organizational skills
  • Detail and results oriented working style
  • Experience with clinical studies in European Union (medical device trials preferred )
  • Detailed knowledge of European and international regulations of Good Clinical Practice (GCP), Experience with Class II & III medical devices preferred, experience with cardiovascular clinical studies preferred, documented basic education/training in clinical research
47

Experienced Clinical Research Associate Resume Examples & Samples

  • Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to one year) or completion of PPD Drug Development Fellowship
  • Customer focus
  • Good English language and grammar skills required; French language skills would be a plus
48

Experienced Clinical Research Associate Resume Examples & Samples

  • 1+ years experience as a field clinical research monitor (CRA) that provides the knowledge, skills, and abilities to perform the job (or completion of PPD Drug Development Fellowship)
  • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment
  • Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays
  • Exposure to biological fluids with potential exposure to infectious organisms
  • Personal protective equipment required such as protective eyewear, garments and gloves
  • Exposure to fluctuating and/or extreme temperatures on rare occasions
  • Ability to work in an upright and /or stationary position for 6-8 hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
  • Frequent mobility required
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf
  • Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
  • Regular and consistent attendance
  • LI-CW1
49

Clinical Research Associates Resume Examples & Samples

  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Development and preparation of the local informed consent form
  • Management of the delivery of study supplies
  • Strong customer focus
  • Effective interpersonal skills
50

Clinical Research Associate, Belgrade Resume Examples & Samples

  • Previous experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities
  • Effective organizational and time management skills
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
51

Trainee Clinical Research Associates Resume Examples & Samples

  • University degree in a science related field or are a certified health professionalMinimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job OR equivalent combination of education, training, & experience
  • Knowledge of ICH-GCP, EU and FDA requirements
  • Excellent English and German skills
52

Experienced Clinical Research Associate Resume Examples & Samples

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
  • May provide assistance to less experienced clinical staff
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Good therapeutic and protocol knowledge as provided in company training
  • Good organizational and problem-solving skills
  • Effective time management skills
53

Clinical Research Associate, Romania Resume Examples & Samples

  • University degree in a science related field
  • At least 1 year independent monitoring experience in clinical development phase II-IV
  • Fluency in English and in Romanian
  • Good organizational and time management skills
54

Senior Manager, Clinical Research Projects Resume Examples & Samples

  • Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
  • Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection
  • Lead cross functional clinical study team to achieve study milestones
  • Interact with internal and external groups to achieve study milestones
  • Determine study requirements, define specifications, and initiate and lead the selection of third party
  • Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and
  • Manage clinical study budgets within agreed variance
  • Communicate clinical studies performance data to other members of the management and medical affairs team
  • Prepare and maintain and/or oversee the preparation and maintenance of required study and regulatory documentation, including but not limited to: study status reports, reports for Competent Authority submissions, informed consent form (ICF), Monitoring Plan, Pharmacy Manual, investigator contracts and budgets
  • Key contributor to the development and/or review and approval of study documents including, but not limited to: protocol, case report forms (CRFs), study procedural documents, ICF, statistical analysis plan, and clinical study
  • May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates
  • May participate in and/or lead department initiatives
  • Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices
  • Develop standard operating procedure (SOPs), as required
  • A solid clinical operations professional with at least 5 years’ experience in clinical research
  • Must have proven technical leadership skills
  • Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes the oversight of internal and/or external stakeholders involved in the following activities: site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, legal review and regulatory affairs
  • Effective verbal and written communication and presentation skills are required in relating to relevant stakeholders both inside and outside the organization
  • Knowledge of team development principles and successful implementation of the same is desirable
  • Track record of effective management and oversight of CROs plus ensuring ICH/GCP compliance and risk management of clinical studies is expected
  • Excellent interpersonal and influencing skills
  • Ability to effectively lead a cross-functional team in a matrix environment
  • Experiencing writing protocols, CRFs and other study-related
  • Proven problem solving and timely decision making skills
  • Excellent leadership, risk management, planning and project management skills
  • Ability to effectively interact with all levels of professionals and support staff
  • Participate in continuous improvement initiatives in the department
  • Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential
55

PRN Clinical Research Technician Resume Examples & Samples

  • Collect, record, and maintain volunteer screening, check-in and study data according to study-specific protocol and SOPs, ensuring quality control for content, accuracy and completeness. Record, report and interpret findings appropriately to develop study-specific database
  • Prepare for clinical trials by organizing and labeling specimen collection tubes and containers, setting up equipment and documents and planning logistical activity for procedures as per study protocol
  • Perform a variety of medical procedures such as venipuncture, collection of vital signs, height and weight measurements, EKGs and stool and urine collections on study volunteers according to study-specific protocols
  • Monitor volunteer safety and report adverse reactions to appropriate medical personnel
  • Maintain and restock medical supplies as needed. Upon conclusion of study, clean clinical areas and equipment; store equipment as necessary
  • Recruit and screen volunteers for clinical trials and maintain volunteer database
  • Bachelor's Degree in Life Sciences preferred
  • Good skill in using MS Windows and Office applications such as Access, Power Point, Outlook and Word
  • Ability to pay close attention to detail
56

Rn-research Clinical Research Department Days CHI Health St Francis Resume Examples & Samples

  • Interpersonal skills necessary to gather and exchange information with physicians, patients, families, visitors and other hospital personnel
  • Analytical skills necessary to develop and implement the coordination, collection, evaluation, and processing of clinical trial data, interpret medical documentation and lab results,
  • Ability to concentrate and pay attention to detail for up to 80% of work time when charting lab work, taking physician orders, scheduling patients and so forth
57

RN Clinical Research Resume Examples & Samples

  • Primary responsibility for this candidate is to manage research protocols by identifying study related elements, evaluating patient eligibility, development of study tools, data collection, data entry and reporting on study participants within study timelines
  • Ability to manage multiple projects and report data on a regular basis while maintaining credibility and confidentiality of all patients. Keeps Physicians, Research Director informed concurrently of study enrollment, adverse events, protocol deviations, protocol violations, study progress, patient visit issues, monitoring visits, updated study requirements
  • Develops and composes professional correspondence to the Institutional Review Board by accurately developing protocol specific informed consents, protocol applications and serious adverse event reporting through the Principal Investigator
  • Ability to resolve queries through accurate supportive documentation. Coordinates and directs both internal and external monitoring visits and audits
  • Responsible for completing Case Report Forms and databases and IRB updates in a timely manner, as well as, resolve all queries generated by the Registry
  • Ability to coordinate protocols and patient visits with all sponsors and provide each sponsor with its protocol data. Obtains necessary follow in adherence with protocols
58

Coord Clinical Research Resume Examples & Samples

  • Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
  • Assists sponsor and US FDA audit teams
  • Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
  • Maintains patient confidentiality according to ethical and legal requirements
  • Assists in providing coverage for satellite clinic sites as necessary
  • Responsible for coverage after hours and on weekends as necessary
  • Medical and research terminology
  • Knowledge of federal regulations, good clinical practices (GCP)
  • Computer skills including use of clinical trial database, electronic data capture, and MS Word or
  • Communicate and work effectively with a diverse team of professionals
  • Organizational and prioritizing capabilities
  • Work independently in a fast pace environment with minimal supervision at off-site facilities
  • Clinical experience- 1+ yrs
  • Clinical research experience- 3 years
59

Coord Clinical Research Resume Examples & Samples

  • Interviews prospective subjects and assure qualifications for participation in clinical trials and obtains informed consent
  • Participates in all assigned study related visits/meetings(investigator meetings may require travel) and implements the assigned clinical trials according to mutually agreed upon timelines by PI and Sponsor
  • Educates subjects for elective participation in our clinical trials
  • Educates clinic/hospital personnel on assigned clinical trials in protocol conduct, data collection process and related issues as applicable
  • Ensures all study related personnel have completed required training and training is documented, before conducting any protocol related activities
  • Actively recruits and exceeds enrollment goals in assigned clinical trials and provides monthly, written documentation of screening/enrollment/follow-up activities
  • Coordinates the collection of data according to the research protocol, operation manual and case report form guidelines within the budgetary guidelines established by the Director
  • Draws, prepares and ships laboratory samples for clinical trials
  • Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines
  • Instructs Principal Investigator on procedures and tests that need to be performed in compliance with the study protocol and advises PI on the results of procedures and testing; calling to attention findings of clinical importance in a timely manner
  • Documents phone conversations with sponsors, study subjects, physicians, coordinating organizations, and any other pertinent resources and place in appropriate source
  • Schedules follow-up visits/procedures for study subjects and provides source documentation for activities conducted during these visits
  • Completes accurate and complete data entry into case report forms or pre-established computer programmed formats in a timely manner
  • Coordinates, schedules and is made available for assigned study monitor visits, quality assurance audits, and query resolution of collected data in a timely manner
  • Identifies strategies for patient enrollment in research studies in collaboration with the PI
  • Report all serious or unexpected adverse events immediately to PI and Research Director
  • Assists in maintenance of research related logs and contact data base
  • Maintains up to date research knowledge through continuing education
  • Actively promotes an open line of communication and a professional relationship with all members of the organization
  • Utilizes appropriate resources to resolve problems. Report any unresolved issues to Director
  • Possess the ability to prioritize and organize high volume workload and flexible with changing priorities to fit the daily needs of the department, patients and customers we serve
  • Knowledgeable of, and adheres to all local, state, and federal research regulations and guidelines
  • Performs any other duties as assigned
60

Clinical Research Associate, Work From Home Resume Examples & Samples

  • Detail-oriented with knowledge of scientific, medical, and regulatory terms
  • Knowledge of ICH Guidelines, GCP, and FDA regulations
  • Understanding of the drug/device development process
  • Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new
  • Professional writing and communication skills
  • Ability to multi-task in fast paced environment is essential
  • Ability to function in a team environment under time and resource pressures
  • Ability to manage, organize, and make decisions
  • Three years direct monitoring experience or equivalent; combination of monitoring experience
  • Three years direct oncology monitoring experience
  • Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and closeout)
61

Clinical Research & Medical Affairs Resume Examples & Samples

  • 2 years of degree level study completed
  • A minimum of 2:1 achieved in first year of study
  • Bio science degree types only
  • High level of accuracy and attention to detail
  • Passion for working in the pharmaceutical/medical industry
  • Highly analytical
  • High level of scientific understanding and intellectual capacity
  • Adaptable and able to work with a wide range of different personalities
  • Excellent communication skills both written and oral
  • Seeks opportunities to learn and grow professionally
  • Able to prioritise and manage own workload autonomously
  • Flexible and adaptable team player
  • Self-motivatedClinical Research MD
62

Senior Assoc Clinical Research Resume Examples & Samples

  • Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study
  • Prepares design validation plans that meet product design goals; intended use; regulatory requirements; divisional operating procedures; and Clinical Research work instructions
  • Prepares clinical protocol; clinical brochure; case report forms; informed consents; and other required documents for clinical studies
  • Identifies and qualifies clinical investigators and clinical sites
  • Proposes and negotiates budgets for clinical studies. Initiates payments to sites
  • Initiates clinical studies and provides for investigator and staff training
  • Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data
  • Monitors clinical studies; ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights; safety; and welfare are protected; ensures data integrity through completeness; accuracy; and legibility
  • Reviews data; prepares and presents clinical data reviews and data summaries
  • Responds to audits and data queries representing a project or team
  • Assists in presentation of clinical information to the FDA
  • Initiates standard publication or presentation of clinical data in professional journals or meetings
  • Functions independently in the field and interacts with all levels of medical and scientific professionals
  • Assumes responsibility for attending training sessions; presentations; and continuing education sessions to expand professional expertise via professional and educational opportunities
  • Serves as a resource person for most technical questions or directs inquiries to appropriate references
  • Accepts and completes all management-directed work assignments such as clinical assignments; travel; and other tasks
63

Clinical Research Operations Specialist Resume Examples & Samples

  • The minimum of a Bachelor’s degree and three to five years experience in clinical/translational research operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) or an equivalent combination of education and experience is required. Master’s degree preferred
  • Direct experience in the following areas
  • Development of protocols, consent forms, and case report forms
  • Operational involvement in multi-site clinical trials
  • Working knowledge of GCP regulations
  • Working knowledge of CMS/GCP/ OHRP/FDA/HIPAA regulations
64

VP, Clinical Research Resume Examples & Samples

  • Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across neurology and pain
  • Direct authorship contributions in protocols and clinical study reports
  • Lead and motivate clinical development medical staff
  • Oversee hiring additional staff as needed
  • Interact with senior management and serve as a standing member of various leadership meetings and Monthly Project Review forum
  • Serve as a primary internal and external spokesperson for Alkermes neurology and pain clinical development programs
  • Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations
  • Generate yearly strategic goals and objectives for the group
  • In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
  • In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required
  • Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards
  • Identify and develop collaborative relationships with key investigators and key opinion leaders globally. Attend and oversee neurology and pain clinical advisory boards and investigator meetings
  • Critically review regulatory submissions (such as INDs and NDAs)
  • Requires a Medical Degree and clinical training in Neurology
  • Strong leadership and collaborative interpersonal skills
  • 10 + years of experience in the pharmaceuticals. Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired
  • Knowledge of safety reporting principles, including global safety reporting regulations
  • Able to perform thorough reviews of various medical and legal documents in a timely manner
65

Clinical Research Associate, Budapest Resume Examples & Samples

  • Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service
  • Conduct monitoring activities independently
  • Ideally 2 or more years of monitoring experience in interventional studies with a CRO, pharmaceutical or biotech company
66

Executive Director of Clinical Research Resume Examples & Samples

  • Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process
  • Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met
  • Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards
  • Lead and motivate clinical staff
  • Develop and review protocols and interact with key external opinion leaders regarding protocol development
  • Collaborate with investigators and study site team members
  • Conduct investigator meetings and site visits
  • Implement and supervise clinical trials, including requests for eligibility and other waivers
  • Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconciling SAE database, MedDRA and WHO coding
  • Advise and troubleshoot any medical problems arising at clinical sites
  • Interact with data management to support data entry including assistance with edits
  • Demonstrate leadership and interpersonal skills
  • Support commercial and marketing team for life-cycle management of approved products
  • Participate in data analysis, publication preparation, and conference presentation
  • Represent clinical development function for other teams’ need including business development and legal related projects
  • Interact with senior management and product team regarding drug development strategy and plan
  • Interact with investigators and key opinion leaders regarding protocol development
  • Write protocols, IB and annual reports
  • Contribute to Clinical Study Reports
  • Write safety section of IND and NDA submissions
  • Help prepare for budgets and progress reports; complete other administrative tasks as required
  • Represent clinical development to support regulatory, safety, manufacture, data analysis and other business need
  • Requires a Medical Degree with clinical experience
  • Requires Hematology or Oncology experience and knowledge
  • Three to 5 years’ experience in the pharmaceutical or contract research industries, or academic clinical research
  • Knowledge of safety reporting principles, including FDA safety reporting regulations
  • Skill in writing narratives
  • Experience with safety database coding
  • Able to work independently, prioritize tasks efficiently and meet expected time frames
  • Able to perform thorough reviews of various medical and legal records in a timely manner
  • Able to interact and collaborate professionally with various departments, regulatory agencies and investigators
67

Manager, Clinical Research Resume Examples & Samples

  • Forecasts, develops and implements policies and procedures in the areas of research compliance, human resources and budgetary goals and objectives that are consistent with University of Utah’s policies
  • Develops and promotes new and existing policies, procedures and programs to internal and external functional groups
  • Participates in oversight committees to establish compliance standards and administrative plans and policies
  • Assures institutional clinical trials are conducted according to University and federal regulations as well as the NCI-approved Data and Safety Monitoring Plan through auditing and oversight of HCI’s Research Compliance Office
  • Develops departmental strategies consistent with the department’s continuous quality improvement program
  • Oversees all aspects of human resource management including recruitment and retention of assigned staff and ongoing staff performance evaluations
  • Ensures competency of clinical research staff working in a complex and regulatory-rich environment through the development and/or presentation of educational programs
68

Manager Medical Writing, Clinical Research Resume Examples & Samples

  • At least 5 years of experience writing clinical research documents
  • May consider less experience with advanced degree
  • Adept in Microsoft WORD
69

Clinical Research Associate, Greece Resume Examples & Samples

  • Excellent standard of verbal and written communication skills in English language
  • Highly organized with strong attention to detail and deadlines
  • Advanced skills across all of the MS Office packages
70

Manager, Clinical Research Administration Resume Examples & Samples

  • Set up and maintenance of program files for internal and external constituents
  • Track third party Clinical Operations vendor agreements with respect to scope, quality, budgets, deadlines/milestones, communication, documentation/administration, and employee resources
  • Assure departmental and corporate compliance with clinical operations SOPs; liaise with Quality Department to document adherence
  • Prepare and support Committee Meetings as defined in the Sponsor and vendor contracts
  • Work with the Finance Department to assure timely invoice processing support for external Clinical Operations vendors and consultants
  • Prepare updates for Donor Development, Marketing and other LLS departments as directed
  • Minimum of 5 years of project administration, management, or process improvement experience
  • Bachelor's Degree required; Master’s Degree preferred with a focus in Project Management, Process Improvement, Business, and/or Operations or in a scientific field
  • Laboratory experience in an academic or biotechnology setting preferred
  • Experience with project management tools and software or ability to learn the software as needed
  • Demonstrated organizational aptitude
  • Proficient in Microsoft Applications; Excel, PowerPoint, Word
71

Clinical Research Data Associate Resume Examples & Samples

  • Bachelor's Degree or equivalent work and/or life experience
  • Proficiency in database and word processing skills, and MS Office
  • Strong customer service skills and an ability to interact cordially with others
  • Knowledge/experience with electronic data submission
72

Manager, Clinical Research Resume Examples & Samples

  • Provide direct oversight for all activities relating to the daily operation of the CDM team in the DCC including making project assignments and setting dates for completion with staff input
  • Responsible for managing the development, initiation, functionality, progress and completion of clinical databases used in clinical studies managed in the DCC
  • Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
  • Hire and directly supervise CDM I-IV staff members. Approve time and attendance
  • Support staff in decision making, project planning and goal setting
  • Communicate regularly with team; share information, provide relevant updates
  • Complete evaluations and promote staff development and education opportunities as appropriate
  • Develop and maintain high quality standards using documented processes and guidelines
  • Function as a lead clinical data manager on cross-functional project team. The lead CDM is responsible for configuration of electronic data capture system, creation of data validation processes and checks, creating reports, and maintaining change control process
  • Oversee initial design and implementation phase for unique network research projects
  • Develop, evaluate and implement new systems and processes used in the management of clinical research information, e.g. medical imaging management systems, and processes for the management and validation of external data sources
  • Act as internal resource for network directors and the director of the DCC to operationalize far reaching research goals and find realistic solutions to unique problems
  • Implement creative solutions and innovative practices as applicable regarding data management practices
73

Clinical Research Technician Resume Examples & Samples

  • Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
  • In the course of biospecimen handling, follow Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Clinical Laboratory Improvement Amendments (CLIA) processes, UAHS and Banner procedures and/or other applicable policies as necessary
  • Follow direction of research staff, investigators, or others involved in the clinical research project work
74

Experienced Clinical Research Associate Resume Examples & Samples

  • Oversight of all sites for a study/ies they are responsible for at a country level
  • Clinical research monitoring experience (minimum 2+ years) that provides the required knowledge, skills and abilities and experience mentoring or training others
  • Effective clinical monitoring skills
75

Regional Clinical Research Associate Resume Examples & Samples

  • Good quality background and experience with healthcare or pharmaceutical development is required
  • Must be driven to deliver quality results on time and in a highly ethical and professional manner
  • Candidate must be willing to travel (up to 25-50%, potential more depending on enrollment). International travel may be required
  • Great organizational and communication skills
  • Proficient in use of Microsoft Office applications
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
  • Ability to write routine reports and/or correspondence
  • Ability to speak effectively before groups of customers or employees of organization and in a high pressure environment
  • Track study timelines
  • Review and track study budgets
  • Provide periodic updates on Clinical Development
  • Provide monitoring support, in some cases functioning as the primary site monitor
  • Assist in writing and review of protocols, amendments, and informed consent forms
  • Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
  • Perform investigative site training
  • Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams
  • Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed
  • Ensure compliance with study-specific procedures
  • 3-5 years of investigative site monitoring or study coordinator/study nurse experience
76

Manager, Clinical Research Resume Examples & Samples

  • Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials
  • Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards
  • Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions
  • Manage standing team meetings to discuss issues related to the CRC/RDC team and clinical trial needs
  • Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight
  • Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans
  • Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency
  • Coordinate with MDG and PIs to provide information on available or competing protocols, workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.)
  • Prepare clinical research reports for PIs, MDGs, HCI Leadership and sponsors
  • Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director
  • Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across MDGs and within the CTO
  • Actively attend and participate in representation of the Clinical Trials Office at MDG and RIP meetings for primary teams and as needed for other Clinical Program Managers
  • Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
  • Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB
  • Facilitate cooperative and collaborative institutional relationships
  • Ensures PI and MDG satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through
  • OTHER: Assume responsibility for additional assignments as directed by the CTO Associate Director
77

Clinical Research Associate, Italy Resume Examples & Samples

  • Qualified as per the Ministerial Decree dated 15/11/2011
  • Ideally 2 years’ monitoring experience in clinical development phase II-IV
  • Fluency in English and in Italian
78

Clinical Research Associate Senior Clinical Site Monitor Resume Examples & Samples

  • 10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV)
  • At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution
  • Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems
  • Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills
  • Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time
  • Ability to successfully manage the designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
  • 1604589
79

Clinical Research Coor Resume Examples & Samples

  • Coordinates daily operations of clinical research studies in Neurology to include assisting Chair & PI(s) with maintaining performance reports, bio-sketches, statistics, analyzing grant development & submission
  • Recruit, enroll, assess, and track participants as they complete protocols for various Neurology studies. Assist Chair & PI in coordinating and performing a wide variety of research related functions including assessments data collection, data entry, interpretation of data and data analysis, collecting blood and biological samples. Must be proactive and timely in all areas of trails; including developing marketing materials for new clinical studies, preparation of study initiations, screening and scheduling study subjects, getting subject consents, and teaching subjects about protocol expectations
  • Facilitates IRB applications for submission and review
  • Assist in pre-award budgets for all faculty related research projects. Assist in monitoring and management of budgets for all research projects to include completing all associated forms
  • Must maintain accurate records and relevant collection of data to assigned patient to include communication, correspondences, and maintenance of pertinent documents related to research
  • Other duties as assigned to include any research trainings
80

Clinical Research Associate, MDS Anemia Resume Examples & Samples

  • With oversight, assist in the management of a region for a study or studies
  • Assist in the preparation of investigator meetings
  • Assist in meetings or conference calls with CROs and multi-disciplinary study team
  • Assist in some aspects of vendor oversight (CRO, Central Lab, Central IRB, IWRS)
81

Clinical Research Coordinator Associate Resume Examples & Samples

  • Some knowledge of psychopathology and psychiatric terms is desired
  • The candidate must possess the necessary patience and resourcefulness to interact well with psychiatric patients, especially children, and their families
  • Basic statistical skills
82

Lymphoma Clinical Research Liaison A Resume Examples & Samples

  • Provide clinical support by quickly and accurately transcribing essential clinic or patient information onto electronic reports as the PI speaks with patients in real-time; check reports for correct punctuation and grammar errors, if any
  • Manage the PI’s calendar, including facilitation of appointments, meetings and conference calls, as well as assistance booking traveling, creating trip itineraries, processing of reimbursement, and attendance of meetings and conferences as requested
  • Prepare/format written correspondence on behalf of the PI, ensuring that all correspondence and other written materials and presentations are accurate and prepared in a timely manner
  • Act as a liaison with various external and internal constituencies on behalf of the PI keeping him apprised of issues and action items on his agenda; establish good working relationships with research partners, research sites, and affiliated organizations
  • Perform comprehensive literature, database and web-based searches with writing of summaries of findings as requested
  • Assist with development and preparation of project-related reports, manuscripts, clinical concepts, research study protocols, and presentations
  • Assist with any relevant submissions to ensure timely adherence to important deadlines, collection, processing and assistance in the compilation and verification of research data, create graphs/figures for data presentations and publications
  • Other duties will be performed for the PI, PM or LCRN as deemed necessary and important
83

Associate Director of Clinical Research Operations Resume Examples & Samples

  • Bachelor’s degree in a field appropriate to the area of assignment
  • Eight or more years of related research experience implementing clinical research protocols including clinical trials and/or cohort studies
  • Three or more years of supervisory experience
  • Master’s degree in a field appropriate to the area of assignment
  • Desire to serve a lively and diverse research community
  • Strong organizational, analytical, and problem­-solving abilities
  • Demonstrated skills in leadership and team-­building
84

Manager, Clinical Research Resume Examples & Samples

  • Bachelor’s Degree or equivalent in a scientific field of study and four (4) years related research experience
  • Knowledge of Good Clinical Practice (GCP)
  • Valid Driver’s License and acceptable driving record at the time of hire
  • Two (2) years previous supervisory experience
  • Research Nurse certification and at least two years of prior clinical research experience are required
  • Six (6) years of prior research experience
  • Master’s degree in Public Health or Healthcare Management is desired
  • Proficiency with information systems and experience investigating costs related to clinical research trials
  • Knowledge of IRB and policies and procedures
  • Strong ability to organize, prioritize, and coordinate multiple activities to meet deadlines
85

Clinical Research Rn-targeted Therapeutics Team Resume Examples & Samples

  • Collaborates with the clinical team in developing all aspects of patient care
  • Assesses patient’s pertinent health history
  • Experience: R.N. with a minimum of 1 year of RN experience
  • Bachelors of Science in nursing (BSN)
  • Knowledge of common pharmaceutical terminology
86

Medical Director, Oncology Clinical Research Resume Examples & Samples

  • Clinical Development team participation and leadership
  • MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions
  • NDA/MAA/Submission experience preferred
  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities
  • Therapeutic area knowledge relevant to mechanism of action
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in designated therapeutic area
87

Associate Director of Clinical Research Resume Examples & Samples

  • The successful candidate will have oversight for ongoing and planned product trials within the Inflammation therapeutic area
  • The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
  • Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
  • Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
  • Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
  • Assists in the clinical evaluation of business development opportunities
88

Director of Clinical Research Resume Examples & Samples

  • The successful candidate will have oversight for ongoing and planned product trials within the Liver Disease therapeutic area
  • The Clinical Research MD will report to a more senior member of the Liver Disease clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
  • Three (3) to five (5) years experience with a proven success record in clinical research studies and trial design is required
  • Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices
  • Experience in Liver Disease drug development
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
  • Strong leadership skills with an ability to set vision, lead change, and mentor others
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
  • Excellent scientific written and oral communication skills
  • Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
  • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected)
89

Site Clinical Research Associate Study Start Resume Examples & Samples

  • Assist with the start-up activities of new clinical trials across Australia and New Zealand
  • Assist in CSMS activities and/or reporting of study information and metrics
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures
  • Assist in completion of activities required for planning and execution of a clinical study
  • Assist in the planning and submission strategies to ensure sites can open our clinical studies as soon as possible
  • Assist in study activities such as preparation of protocol and informed consent, investigator/site selection, investigator meeting and contract preparation, and other activities to ensure on time completion of studies
  • Assist in negotiation and execution of study budgets and contracts with study sites
  • Participate in all study activation activities
  • Assist in driving efficiencies within the start-up function
  • Prioritize activities to ensure study timelines are met
  • Study Contributor
  • Assist in development of study/site budgets and vendor contracts
  • Requires moderate level of oversight and guidance
90

Prin Clinical Research Spec Resume Examples & Samples

  • Experience working with Health Authorities around the world, specifically PMDA
  • Ability to supervise others over the execution of a trial
  • Customer focusedComputer skills (MS Office products, word processing, spreadsheets, etc.)
  • Ability to independently lead a study team and trial with little supervision
  • Excellent understanding of biostatistics and trial design
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011
91

Clinical Research Medical Director Resume Examples & Samples

  • Provide medical expertise specific to US
  • Provide consolidated feasibility and site selection input to global and US teams
  • Perform local AE review and provide general medical support for safety issues
  • Be aware of clinical trial SAEs on a country level
  • Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials
  • Support ICRO/ and Global teams in interaction with regional regulatory agencies
  • Provide assistance to ICRO and site for IEC/IRB Interactions
  • Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
  • Demonstrates a high level of understanding of the protocol to train others on the protocol including site personnel where applicable
  • Demonstrates understanding of the protocol to evaluate investigator / site patient protocol compliance and patient safety
  • Ability to manage a study from the medical perspective, and a demonstrated capability to problem-solve and mediate complex medical / operational issues within the regional and therapeutic area context
  • A minimum of two years pharmaceutical industry or clinical trial management experience required
92

Clinical Research Technician Resume Examples & Samples

  • Manage clinical trial documentation such as CRFs (case report forms) and DCFs (data clarification files) within Data Management. This activity includes distributing DCFs, tracking and filing of DM project documentation
  • Interact with CDM staff, management, and other project team members to resolve issues and provide status information
  • Assist Data Operations Coordinator/Data Team Lead in the creation and maintenance of the Data Management Study File and Data Management Plan (Data Tracking Guidelines) and other project files
93

Clinical Research Application Specialist Resume Examples & Samples

  • Bachelor’s degree in Clinical Research, Science, Health Sciences, Information Technology, Business or related field
  • One year experience working with web-based applications/information systems in a healthcare, finance, or other highly-regulated environment
  • Prior experience in building calendars with OnCore at an academic medical center is preferred
  • Experience with other CTMS or financial data systems in support of clinical research is desirable
  • Experience providing technical support to customers
  • Demonstrated knowledge of study design criteria, randomization processes, clinical and bio-specimen terms used in research studies, and scientific and medical concepts and terminology
  • Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research
  • Knowledge of medical billing terms and research billing operations for industry, institutional and national group -sponsored research
  • Diplomatic disposition and customer service orientation with excellent written and verbal communication skills
  • Detail-oriented self-starter with outstanding interpersonal skills, and a reputation for establishing and maintaining good customer and end-user relations
  • Comfortable asking questions, working with minimal supervision, and collaborating with coworkers in a team environment on complex projects
  • Quick and agile learner, able to adapt to changes in technology and its intended use
  • Able to synthesize complex clinical trial information in order to facilitate decision making
  • Proficiency in Microsoft Windows and Office, including advanced skills in Excel
  • Familiarity with terminology and processes associated with all phases of clinical research
94

Group Head, Clinical Research Resume Examples & Samples

  • Lead or oversee the creation of clinical strategies and clinical development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • Manage, oversee and develop Clinical Research direct reports, building the group’s capabilities in support of the needs of our evolving development portfolio. Coach, train, and/or mentor employees to optimize their performance
  • Identify program issues and develop sound strategic solutions with clinical teams to ensure their timely resolution
  • Be the recognized clinical expert for assigned development program/s both within and external to Ironwood
  • Provide medical input into the design of clinical trials for these development programs. The Clinical Research group will design scientifically rigorous and cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices
  • On assigned programs, serve as a medical monitor for clinical studies (provide medical oversight of the study; address eligibility questions; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of high quality clinical trials that meet key milestones, maintain timelines and keep within budget
  • Assist in the preparation of clinical protocols and Regulatory documents (eg., INDs, annual reports, FDA/EMA meeting requests, briefing books, and NDAs) and other relevant clinical documents
  • Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities
  • Contribute actively to the Clinical Affairs leadership team, relevant governance bodies, and process improvement initiatives
  • Collaborate effectively with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
  • Provide clinical, scientific and development expertise to business development projects and diligence
  • An MD or DO degree, with internal medicine expertise
  • Eight or more years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3, through registration, and post-approval
  • Strong strategic thinker who can provide vision and purpose for teams and a drive for results
  • Possesses thorough understanding of operational aspects of clinical research and development
  • Strong general knowledge of regulatory requirements, including principles of GCP, ICH and CFR, that apply to clinical development, with significant experience interacting directly with Health Authorities
  • Three or more years of people management experience, with demonstrated ability to motivate, mentor, develop and lead other physicians in clinical research
  • Able to set priorities for team, establish clear direction and objectives and maintain accountability
  • Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment
  • Persuasive, effective and flexible in interpersonal interactions at all levels, with outstanding oral and written communication capabilities
  • Effective relationship management skills with internal and external partners
  • Strong analytical, decision-making, project management and problem-solving skills
  • Specialty training and board certification, or expertise in gastroenterology, rheumatology or nephrology would be ideal, but is not required
95

Clinical Research Coordinator Pediatric Anesthesia Resume Examples & Samples

  • Demonstrated clinical and/or research experience in Anesthesia and/or Pediatrics
  • Knowledge of EPIC based electronic medical record systems
  • Experience in clinical trials management, including writing and submitting IRB applications, protocol revisions and consent
96

Clinical Research Operations Manager Resume Examples & Samples

  • Extensive experience in clinical research as a coordinator, research nurse, data manager or clinical project manager
  • CCRC certification, excellent knowledge of Good Clinical Practices and Regulatory requirements for clinical research studies
  • Demonstrated leadership and supervisory skills including conflict resolution
  • Strong financial expertise in accounting, budget planning and financial forecasting
  • Strong expertise in grants and contract administration
  • Strong negotiation and interpersonal skills
  • Strong knowledge of industry standards and/or regulatory requirements
97

Non-clinical Research Protocol Manager Resume Examples & Samples

  • Minimum of 7 years work experience within the pharmaceutical industry
  • Knowledge of preclinical/nonclinical research
  • Demonstrated Excel and analytical skills
  • BA/BS degree in a life science field
  • US military experience will be considered towards industry experience requirements
98

Clinical Research Associate Trainee Resume Examples & Samples

  • Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance
  • Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
  • Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager
  • Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
  • Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
  • Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Strong written and verbal communication skills including good command of English language
  • Excellent organizational and problem-solving skills
  • Ability to manage competing priorities
99

Clinical Research Associate, Oncology Resume Examples & Samples

  • You will be responsible for ensuring that, at the site level, the Clinical Monitoring Plan is implemented
  • Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials in general
  • Experience of performing site start up procedures, routine monitoring and site closure
100

Manager of Clinical Research Resume Examples & Samples

  • Education: Bachelor's degree required. Degree in health sciences or business preferred
  • Experience: Minimum of five years’ experience in clinical research required. Customer service experience in a medical office or hospital setting preferred
  • Licensure/certification/registration: National Research Organization required
101

Director, Regional Clinical Research Resume Examples & Samples

  • Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners’ (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer
  • Attends educational workshops
  • Review professional publications
  • Participates in professional societies
  • Proficient in Microsoft applications
  • Contacts with pharmaceutical companies and clinical research organizations
102

Manager of Cardiology Clinical Research Sites Resume Examples & Samples

  • Knowledge of organizational policies, standard operating procedures and systems
  • Public presentation skills
  • Interpersonal skills
  • Cardiology experience
  • Management experience
103

Clinical Research Medical Director Resume Examples & Samples

  • Supporting the development, execution and communication of the global scientific/medical evidence plan
  • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Supporting the development of key scientific external relationships with opinion leaders
  • Participating and providing clinical input into safety and regulatory interactions
  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics
  • Sound scientific and clinical judgment
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
  • Two (2) or more years of clinical research experience and/or basic science research
  • MD plus accredited residency in relevant sub-specialty, board certified or equivalent
  • Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
104

Clinical Research Study Leader Resume Examples & Samples

  • Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality
  • Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
  • Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders
  • Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
  • For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle
  • Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
105

Clinical Research Coordinator Ophthalmic Resume Examples & Samples

  • Ideal candidate will have prior working in clinical research, with a specific emphasis on project management, either as a clinical research coordinator or regulatory coordinator
  • Professional clinical research certification (ACRA or SoCRA) is desirable but not required
  • Prior experience within ophthalmology, or prior ophthalmic technician training / certification is NOT required
106

Senior Director of Clinical Research Resume Examples & Samples

  • A minimum of a Bachelor’s degree in Biological Science or related discipline, with a minimum of 10 years related scientific / technical experience, including leadership / management role within Clinical Research for at least 8 years
  • With a PhD or Masters, these requirements would be a minimum of 8 years related scientific / technical experience, with at least 6 years of management within a Clinical Research role
  • People management experience is required
  • Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required
  • Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM projects is required
  • Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is preferred
  • Comprehensive understanding of clinical trial regulations across multiple regions is required
  • Ability to lead teams to deliver critical milestones is preferred
  • Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is preferred
  • Experience in effective management of platform budget processes is preferred
  • Neurovascular experience is preferred.Clinical Research non-MD
107

Site Clinical Research Associate Resume Examples & Samples

  • Clinical Project& QualityManagement
  • Conduct site qualification including analysis and recommendation, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes
  • Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
  • Minimum of 1 year of clinically-related experience, of which 6 months must be in clinical research monitoring [R1]
  • Demonstrated strong site management and monitoring skills
  • Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
  • Good written and verbal communication skills both in English and in the local language
  • Exhibit high degree of flexibility when facing changes in the work environment
  • Previous experience with electronic data capture systems desirable
  • Strong ability to work independently with minimal supervision
108

Clinical Research Medical Director Resume Examples & Samples

  • Supporting the development, execution and communication of the global scientific evidence plan
  • MD plus accredited residency in inflammation or oncology, board certified or equivalent
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
  • In-depth understanding of clinical development and concepts of clinical research and clinical trial design, including biostatistics
109

Clinical Research Study Leader Resume Examples & Samples

  • Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
  • With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives
  • Conducts protocol and site feasibility assessments to ensure optimal site selection
  • Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
  • Proactive management of all aspects of the study
  • Manages both internal and external partners
  • Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
  • Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
  • Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
  • CRSL may provide support and mentoring to other CRSLs
  • Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team
110

Clinical Research Coordinator Associate Resume Examples & Samples

  • Familiarity with Breast Cancer resources in the Bay Area is a plus
  • Experience with recruitment of research participants for clinical studies
  • Familiarity with EPIC is a plus
111

Clinical Research Coordinator Associate Resume Examples & Samples

  • Advanced Degree
  • Board Certified Behavior Analyst
  • Experience in working with children with intellectual disabilities and teaching social skills
112

Clinical Research Coordinator Healthcare Resume Examples & Samples

  • To serve as coordinator for both single and multi-center, investigator initiated and industry sponsored, clinical studies, with responsibilities to include participant recruitment and retention efforts, medical record data extraction, data entry, and management of IRB and other regulatory matters related to clinical research under the instruction and direction of investigators
  • Requires Bachelor degree in a science or health-related field or equivalent education and experience
  • Extensive experience with successful submissions to IRB
113

Clinical Research Finance Manager Resume Examples & Samples

  • BA/BS degree with a major in a health or business related field and 5 years of applicable experience or an equivalent combination of education and experience required
  • Strong, proven experience as a supervisor required
  • Strong working knowledge of CPT coding and medical terminology required
  • Basic understanding of third party payor and sponsor reimbursement policies and standards of practice
  • Computer proficient – must have strong Excel, Word, presentation, and database skills
  • Ability to effectively collaborate with multiple departments and a strong team work ethic
  • Ability to work independently with self-motivation and initiative
  • Strong organizational and analytical skills and attention to detail
114

Clinical Research Analyst Resume Examples & Samples

  • 2+ years of clinical coding experience
  • 3+ years of relevant analytics experience
  • 3+ years of healthcare or pharmaceutical industry experience
  • Knowledge of health care claims, products, data and systems
  • Preferred experience in working in a data warehouse environment as well as the ability to work with large data sets from multiple data sources
  • Experience of project work, specification and testing
  • SQL/SAS programming skills (e.g., SAS Base, SAS STAT, SAS Macros)
  • Knowledge of analytic programming tools and methods (SAS, SQL, OLAP, Business Objects, Crystal)
115

Clinical Research Associates Resume Examples & Samples

  • Two up to four years of clinical monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)
  • Oncology experience would be a plus
  • Good communication, planning, organization and problem solving skills
116

Clinical Research Associates Resume Examples & Samples

  • Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
  • Completing Serious Adverse Event (SAE) reporting, processing production of reports
  • Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned
  • Assist with training, mentoring, and development of junior employees, e.g. co-monitoring (for CRAs II and SCRAs)
  • Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs)
  • Fluency in Czech and English language
117

Clinical Research Associates Resume Examples & Samples

  • Recruiting potential investigators, working with start-up department for EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor
  • Minimum 1 year of monitoring experience in pharmaceutical or CRO industries
  • Fluency in local and English language
118

Clinical Research Resume Examples & Samples

  • Directs and oversees Clinical Development/Operations and Regulatory Affairs process for a research and development services provider conducting clinical trials of experimental vaccines and biologics
  • Develops study protocols and creates standards and guidelines for clinical research services and programs
  • Ensures adherence to standard operating procedures, good clinical practice and FDA regulations
  • Coordinates inspection of the organization and contract facilities, and coordinates regulatory submissions and Agency interactions
  • Active/current Secret clearance is required (interim Secret is also acceptable)
  • Master’s Degree with at least 12+ years of experience in the field is required
  • Familiarity with a variety of the field's concepts, practices, and procedures
  • Must rely on extensive experience and judgment to plan and accomplish goals
  • Must have a wide degree of creativity and latitude
  • Must be willing to travel occasionally
  • PhD with 9+ years of relevant experience
119

Clinical Research Administrative Director Resume Examples & Samples

  • Maintains investigational drug and drug accountability adhering to all NIH, NIAID, NINDS and other applicable federal pharmacy guidelines
  • Maintains copies of each protocol that is IRB approved including all subsequent amendments and versions while adhering to all institutional and federal guidelines
  • Maintains copies of the first and last pages of signed current informed consents that have been approved by the IRB for each protocol
  • Maintains all current FDA form 1572s and Investigator of Record (IoR) forms and signature pages
  • Ensures that outpatient dispensing is done according to guidelines in the most current IRB approved version of all protocols
  • Liaises with protocol principal investigators to establish pharmacy’s role in the trial for study drug compounding, packaging, and dispensing
  • Liaises with external agencies/organizations, as required
  • Monitors pharmacy activities to ensure adherence to study protocols and dispensing procedures
  • Communicates with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial
  • Maintains a pharmacy binder (paper or electronic) which contains a study summary, protocol, dispensing procedures, dispensing checklist, and any other relevant materials for each investigational trial
  • Available by prior scheduling request to dispense medications if needed for after-hours
  • Maintains investigational drug inventory
  • Performs an ongoing perpetual inventory and a monthly total inventory of all investigational products
  • Responsible for correct ordering, storage, dispensing and return of investigational agents according to IRB, state and federal (NIH, FDA) requirements
  • Maintains investigational research database for assisting with drug accountability, dispensing and return of investigational products
  • Attends bi-weekly staff meetings
  • Participates in all new study start-up meetings
  • Serves as an educational resource to study participants and other staff regarding drug dispensing, dosing allowed concomitant medications, and drug interactions with non-study medications, other dosing requirements (food effects, etc)
  • For each research study, correctly stores, dispenses, and records investigational product according to sponsor’s instructions, participant’s randomization; maintains study blinding where appropriate
  • Orders new study-specific inventory in a timely fashion so that study drug administration is uninterrupted
  • Returns unused study drug to sponsor according to study-specific requirements
  • Cooperates with study monitors during site visits to facilitate oversight on study drug storage, dispensing and accountability
  • Constructs and maintains Pharmacy Plan and all standard operating procedures as needed for the investigational pharmacy
  • Completes all required research training and maintains certificates of Good Clinical Practice and Human Subjects Protection as required by institution, State and Federal Agencies (e.g., NIH, FDA, OHRP)
  • Maintains Ohio Pharmacist license in accordance with Ohio State Board of Pharmacy
  • Maintains Ohio Pharmacy License for the Clinical Trials Research Pharmacy in accordance with the Ohio State Board of Pharmacy, including required text books
  • Supervises research pharmacy technician as required. Delegates work assignments and checks work orders filled by technicians
  • Fulfills all requirements to serve as StrokeNet National Coordinating Center Central Pharmacist
  • Coordinates time off with back up pharmacist
  • Attends annual ACTG, HPTN, StrokeNet and other Network meetings as required
  • Ohio License from State Board of Pharmacy
  • RPh or PharmD
  • Ability to Obtain Independent Pharmacy Licensure from State Board of Pharmacy
  • Eligibility to apply for an institutional DEA license
  • Eligibility to apply for a wholesale license
  • Meticulous documentation skills
  • Previous experience with investigational drug management preferred but not required
120

Clinical Research Monitor Based Inspain Resume Examples & Samples

  • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
  • Excellent problem solving skillS
  • Experience of conducting clinical research activities in a regulated environment
121

Clinical Research Senior Program Resume Examples & Samples

  • Bachelor's Degree, preferably in a Business, health-related, scientific or engineering field
  • Minimum 4 years of experience within a Business Analyst and/or project management role (2+ years with Masters or Doctorate degree)
  • Project Management Certification (preferably PMI) - preferred
  • Green Belt Certification – Ongoing use of Six Sigma tools (Process map, C & E, FMEA’s, Risk Analysis, etc.) - preferred
  • Able to clearly communicate with all levels of management while collecting business needs and requirements
  • Proficient in MS Office Suite of Products; Word, Powerpoint, Visio, Project (ex: customization of fields, tables, views; modifying reports; analysis of critical path.) and Excel (ex: pivot charts, vlookups, graphs, truncating text, etc.)
  • Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk, procurement, and stakeholders as defined by Project Management Body of Knowledge)
  • Enthusiasm towards process improvements and change management
  • Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership
  • Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
  • Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
  • Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback
  • Flexibility to adjust quickly and effectively to frequent change and altered priorities
  • Candidates with work experiences in pharmaceutical, medical devlice and/or CRO industries are preferred
  • Practical experience performing project management for a cross-functional project
  • Critical chain project management certification or experience with application of critical chain project management principles
122

Clinical Research Associate, Dcri-outcomes Resume Examples & Samples

  • Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. two years directly related clinical trials research experience; or
  • Completion of a bachelor's degree plus a Minimum of three years directly related experience in clinical trials research; or
  • Completion of a bachelor's degree plus a minimum of four years closely related research experience
123

Clinical Research Coor-clinical Research Institute Resume Examples & Samples

  • Develop and maintain relationships with faculty members interested in or currently conducting clinical research
  • Develop and maintain relationships with assigned pharmaceutical, medical device, and other medical manufacturers considering clinical trials
  • Actively market the Clinical Research Institute
  • Facilitate IRB application and submission via iRIS system
  • Facilitate ongoing and timely communication with the IRB via iRIS system
  • Recruit and enroll human subjects while protecting subjects and subjects’ rights
  • Maintain Study files/documents on all assigned studies
  • Facilitates data quality and integrity
  • Assist with development and management of research study budget
  • Assist faculty/staff with development of research protocols
  • Assist with clinical research education and training of volunteers, students, new employees
  • Attend affiliated clinical research meetings and professional meetings where research and compliance training may occur
  • Obtain SoCRA (CCRP) or ACRP (CCRC) certification when eligible
  • Maintain CPR certification
  • Maintain IATA training/certification
  • Maintain required institutional training to be able to participate in Clinical Research activities (i.e. CITI and HIPAA research training)
  • Obtain/Maintain ACLS certification
  • Participate in the Clinical Research call schedule rotation as needed
  • Obtain and maintain appropriate credentialing approval from University Medical Center's Medical Staff office
  • Healthcare related training with current licensure/certification in their field. OR
  • Bachelor's degree from an accredited university with a major in the area of research being conducted
124

Specialist Clinical Research Resume Examples & Samples

  • Reviews protocol and Case Report Forms (CRFs) during the development process and contributes to enrollment /randomization/blinding procedures
  • Serves as a Clinical Trial Systems Administrator for related system functions including study configuration and assures appropriate study integration
  • Responsible for initiating timely payments to the sites and communicating with Clinical Planning/Finance
  • Monitors study progress and routinely interacts with study team members and management to inform them of PSM issues that may impact study milestones
  • Works closely with study site personnel to resolve issues, e.g. payments, supplies, enrollment/randomizations, product accountability
  • Performs randomization, product accountability and supply reconciliation for assigned studies
  • Manage research supplies and related study needs including permission of tools/questionnaires, clinical file archiving
  • Assure management and control of product throughout lifecycle
  • Responsible for conducting assigned responsibilities in compliance with applicable Abbott Policies and regulations
  • Participates in various organizational committees and develops work flow process improvements for department procedures
  • Plays an active role as trainer for purposes of cross-training or for educating new PSM employees; often assists with formal or informal training of study personnel and study team members outside of PSM regarding roles and responsibilities
  • Serves as a PSM subject matter expert for study teams and cross functional stakeholders understanding of research processes
  • Flexible, well organized, and strong communication and interpersonal skills
  • Works well under pressure, with initiative to take on unfamiliar tasks
  • Basic and some advanced computer skills (includes word processing, spreadsheets, instrumentation related to Abbott network systems and advanced technical software)
  • Team oriented, with high energy and desire to achieve results. Ability to work in multidisciplinary teams and meet business goals
  • BA in health profession or scientific related field preferred
  • 0-5 years’ experience in the clinical research industry preferred
  • Knowledge of Good Clinical Practice and research industry standards preferred
  • Proficiency with clinical systems and/or experience with clinical trial management systems preferred
125

Clinical Research Medical Director Resume Examples & Samples

  • MD plus accredited residency in relevant sub-specialty
  • Board certified or equivalent
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in Neuroscience
  • Strong background in neurodegenerative diseases with expertise in AD highly preferred
126

Clinical Research Quality Auditor Resume Examples & Samples

  • A Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
  • At least 3 years in clinical research in industry or academia
  • Proven auditing ability
  • Demonstrated ability to prioritize own work and multi-task
  • Ability to routinely and independently exercise sound judgment in making decisions
  • Relevant subject matter knowledge
127

Rwlpr Clinical Research Associate Resume Examples & Samples

  • Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
  • This includes pre-award activities, oversight of the scope of work, budget and resources
  • Developing and implementing the RSU Management Plan
  • Ensuring collaboration across RSU, including communication with regions and countries
  • Assisting with the creation and review of core scientific, technical and administrative documentation
  • Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
  • Ensuring overall project efficiency and adherence to project timelines and financial goals
128

Clinical Research Coordinator Associate Resume Examples & Samples

  • BA/BS or MA/MS
  • Experience with social science research and/or clinical trials
  • Knowledge of eating disorders
129

Clinical Research Coordinator Healthcare Resume Examples & Samples

  • MRI/fMRI collection, processing and analysis, and interpretation
  • Maintain research appointments calendar
  • Writing programing scripts to streamline data processing and analysis
  • Assist in making appointment reminder calls to research participants
  • Cancel and reschedule appointments as needed
  • Place research notes in MiChart as needed
  • Perform general office and administrative duties as assigned
  • Other duties as directed by the Principal Investigator
  • Bachelor’s degree in Neuroscience
  • Computer proficiency (e.g. Microsoft Word, Excel, Power Point and EndNote), including programming languages (i.e., Python, FreeSurfer, R, Matlab, Swift, C & Git)
  • Extensive experience (5+ years) with processing and imaging analysis platforms such as Freesurfer, FSL, and SPM
  • Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
  • Previous experience working on fMRI analysis
  • Outstanding organizational skills with meticulous attention to detail
  • Proven ability to work independently with minimal supervision
  • Ability to problem-solve and establish timelines and priorities
  • Available to work some evenings and weekends as necessary
  • Ph.D. degree in Neuroscience with post-doctoral training on brain imaging and biomarkers
  • Experience working with older adults and veterans
  • Experience working and interacting with research participants
  • Experience with Electronic Data Capture
  • Proficiency in using statistical analysis packages such as SAS and SPSS or other research laboratory programs
  • A working knowledge of medical terminology and assessment of laboratory values
  • Additional Information
130

Clinical Research Assoicate Resume Examples & Samples

  • Must possess 2+ years of oncology experience
  • Experience in monitoring clinical trials required
  • Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
  • Ability to reason independently and recommend specific solutions in clinical settings
  • Understand current GCP/ICH guidelines applicable to the conduct of clinical research
  • Valid driver’s license; ability to rent automobile
131

Field Clinical Research Associate, Senior Resume Examples & Samples

  • Strong preference for prior clinical monitoring experience
  • A general familiarity with cardiac, vascular, and/or neuromodulation technologies Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
  • Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution
132

Clinical Research Coordinator Healthcare Resume Examples & Samples

  • Management of clinical research studies including patient screening and enrollment; study medication accountability; database management; coordination of study visits, labs and procedures; documentation and communication with physicians, study coordinators and sponsors
  • Coordinates the submission of clinical study materials to IRB and other regulatory agencies for approval
  • Collects specimens and monitors subjects. Assists in the reporting of tests results
  • Attend investigator and coordinator meetings
  • Serve as a resource and contact person for active protocols
  • Critique study protocols and assist with budget
  • Bachelor’s degree or equivalent professional degree and documented 5 years’ clinical research experience
  • Ability to communicate effectively and follow written and verbal instructions
  • Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment
  • Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines
  • Ability to effectively work with diverse teams as well as independently
  • Demonstrate efficient organizational skills and ability to effectively problems solve and implement solutions to improve processes
  • Excellent interpersonal and conflict resolution skills
  • Takes initiative in process improvement and functions in self-directed manner and demonstrated willingness to be flexible where needed
  • Understanding of IRB and applicable regulatory guidelines
  • Proficient use of computers and applications including Microsoft Word, Excel, PowerPoint, EndNote, Microsoft Access and SPSS
  • SOCRA certification
  • Knowledge of and experience with UMHS basic research, ULAM and UCUCA policies and procedures
  • Prior experience with laboratory administration and finance
133

Assistant, Clinical Research Resume Examples & Samples

  • A minimum of an Associate Degree with minimum 2 years of industry experience is required or H.S. diploma with a minimum of 8 years of industry experience required
  • Previous experience with study coordination is preferred
  • This position may require up to 10% domestic travel
  • This position is required to be based in Skillman, NJ.Clinical Trial Coordination
134

Site Clinical Research Associate Resume Examples & Samples

  • Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas
  • Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline
  • Report monitoring activities and study site conduct accurately and completely
  • Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues
  • Supports remote monitoring, if and as applicable
  • Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
  • Candidate should be located in Missouri
  • Exhibits high degree of flexibility when facing changes in the work environment. Attention to detail and strong interpersonal skills
  • Previous experience with electronic data capture systems is desirable
135

Clinical Research Asssociate Trainee Resume Examples & Samples

  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties
  • Gain experience in study procedures by working with experienced clinical staff
  • Under close supervision, perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
  • Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Bachelor's degree, preferred in health care or other scientific discipline; or equivalent combination of education, training and experience
136

Neuroimaging Clinical Research Coordinator Associate Resume Examples & Samples

  • 2-3 years of related experience in subject recruitment, assessment, and analysis related to brain imaging research
  • Technical experience in running MRI scans
  • Proficiency with basic programming and scripts
  • Desired experience in
  • Neuroimaging analysis with extensive experience with analysis toolkits and frameworks: SPM, FSL, AFNI, Nipype, Freesurfer, Murfi (Multivariate and Univariate Realtime-fMRI imaging), open fMRI
  • Experience in Cognitive experiment stimulus creation: E-Prime
  • RedCap experience desired
137

Clinical Research Associate, Device Resume Examples & Samples

  • Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC
  • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required
  • May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA
  • Attends study-related, company, departmental, and external meetings, as required
  • Ability to handle several priorities within multiple, complex trials
138

Clinical Research RN Phase Resume Examples & Samples

  • May be called upon to perform the following specific tests and procedures specifically related to the research study: a) electrocardiogram, b) blood pressure, pulse, height, weight, and temperature measurements, c) phlebotomy and specimen processing and shipping, d) pulse oximetry
  • Bachelor’s degree in Nursing or other related field
  • Excellent interpersonal, communication, organizational skills, and ability to problem solve and multi-task
  • Ability to perform common RN duties such as: drug administration, infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures
139

Clinical Research Clinical Associate Resume Examples & Samples

  • Prior research experience required
  • Experience with statistics and big data highly recommended
  • Biology or health sciences background preferred
  • Interest in authoring publications preferred
  • Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience
140

Technician, Acpru Clinical Research Resume Examples & Samples

  • Communicates and interacts in a professional manner with AbbVie Clinical Pharmacology Research Unit (ACPRU) personnel, study projects, and other internal/external departments
  • Maintains accurate and complete source data in PIMS and/or the source documents and communicates source discrepancies or issues, as appropriate
  • Performs study-related protocol activities, i-e., ECGs, blood draws, meals, etc…as assigned
  • Maintains safety and confidentiality of study subjects throughout the study and communicates safety related information in an appropriate manner
  • Assists with the training of entry level Research Technicians and provides feedback of trainees progress on a regular basis
  • Participates in quality and compliance improvement projects
  • Understands and complies with SOPs, FDA regulations, basic GCP requirements and identifies potential risk of compliance deficiencies
  • Maintains volunteer database with prompt and timely updates and informs the R&S Clinical Research Nurse of progress
  • Performs phone interviews regarding the volunteers eligibility based on the inclusion/exclusion criteria and refers issues to the R&S Clinical Research Nurse as appropriate
  • Performs pre-study R&S setup i-e. R&S calls, document preparation, laboratory set-up, label preparation, lab ordering, performance of QC checks, and inclusion/exclusion sign-off and obtains confirmation from the R&S Clinical Research Nurse as appropriate
141

VP, Clinical Research & Medical Affairs Resume Examples & Samples

  • Interact with Cerus management to define and develop clinical strategies consistent with business objectives and regulatory requirements
  • Direct activities related to phase 1-4 clinical trials (e.g., protocol development, design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, and study analysis and reporting)
  • Provides clinical input into target product profile and commercial planning activities
  • Ensure CRMA adherence to national and international regulations and standards (GCP, MDD, ICH)
  • Lead interactions with Steering Committees and Data Monitoring Committees
  • Oversight of adherence to protocols and regulatory requirements, assuring safety of study subjects
  • Write medical monitoring plans. Review adverse events, monitor safety and prepare analysis and regulatory submission
  • Participate in the review and editing of regulatory submissions and quality documentation
  • Interact with Marketing, Product Development, Medical Science Liaisons, Hospital Implementation and Global Scientific Affairs for strategic positioning and support of clinical trials and needed medical data
  • Interact with Regulatory Affairs for positioning regulatory strategy
  • Cultivate and maintain key relationships with outside business partners, scientific and clinical advisors, and therapeutic thought-leaders
  • Oversee operational activities and CRMA personnel including clinical research, drug safety and biostatistics
  • Manage and participate in human resources/organizational development activities including; recruitment of key CRMA personnel, performance management, employee development and training
  • Draft annual clinical budgets and ensure budgets and schedules are met
  • Participate in scientific publications and presentations; and review of publications to insure consistency with corporate objectives
  • Provide clinical trials result data in medical journals and present results at conferences and symposiums
  • Ensure quality system compliance as it relates to area of responsibility
  • MD degree: Prefer Board Certification (or Eligible) in related field (e.g., Hematology, Transfusion Medicine, Internal Medicine, Pediatrics and Infectious Diseases)
  • Minimum of 10 years clinical trial experience; includes 5 years management background and 5 years clinical/drug/medical device development experience in the biotechnology or pharmaceutical industry
  • Demonstrated significant, successful ability to conduct clinical development in an industry setting, including IND, NDA, PMA or BLA filing experience
  • Thorough understanding of regulatory requirements
  • Strong negotiation skills to influence policy making bodies both internally and externally
  • Ability to integrate clinical expertise with Cerus business objectives; strong sense of Company with ability to translate corporate goals into project plan
  • Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented
  • Ability to effectively communicate (encompasses verbal, written, interpersonal, listening); ability to communicate across multiple disciplines successfully (internally and externally)
  • Needs to be comfortable, and indeed thrive in a flexible, dynamically changing and challenging environment
  • Willing and able to travel up to 30% of the time
142

Clinical Research Medical Director Resume Examples & Samples

  • Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
  • Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
  • Supporting clinical trial conduct
  • Participating in engagement of external key stakeholders (often in partnership with other functions)
  • Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • Supports implementation of Medical governance for respective product, which includes
  • 2+ years of Clinical, Research or Medical Affairs experience
  • Accredited fellowship in Rheumatology
  • Board certified or board eligible
  • Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with clinical study management and conduct
  • Familiarity with US health care compliance considerations
  • Experience with opinion leader interactions
  • Experience with integrated delivery networks, accountable care organizations, and payers
  • Broad and formal leadership experience
143

Clinical Research Dev Lead, Early Development Resume Examples & Samples

  • MD/DO with experience in vaccinology / immunology
  • Minimum 3 years industry experience or
  • 10 years experience working in a scientific or medical institution
  • Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP
  • Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape
  • Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum
  • MD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology
  • Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks
  • Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making
  • Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences
  • License to practice medicine and board and/ or professional certification is an asset
144

Clinical Research Psychologist Resume Examples & Samples

  • Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to)
  • Retrieve, sort and collects data from hard copy and electronic database
  • Manage data processing applications, maintain hard copy and electronic files and is accountable for accurate and timely processing of all research data
  • Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft Power Point, and statistical software such as SPSS in order to analyze data and produce reports
  • Perform a variety of duties concerned with the collection, analysis, evaluation and dissemination of DMH-related research
  • Serve as an investigator on protocols related to human research
  • Provide technical support for these studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
  • Collect and maintain data for ongoing research and academic protocols in the DMH
  • Establish and maintain electronic records of current and past research, academic activities such as lectures and training courses, and publications, including original research, case reports, text books, letters to the editor, book chapters, etc
  • Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design
  • Maintain research packets for use by investigators in the DMH
  • Contact study enrolled patients via telephone, email, or in person as needed for data collection for research protocols
  • Alert investigators to Institutional Review Board (IRB) deadlines, by serving as liaison between the Clinical Investigation Department and the DMH
  • Assist investigators with or independently create and prepare materials for initial reviews, continuing reviews, and terminations of research protocols as required by the IRB or IACUC
  • Establish schedules to meet required protocol timeframes, facility availability, and investigator work schedules
  • Receive individual assignments from Staff and Residents which involve specialized and/or short-term studies; identifies information sources, collects, researches and assembles background data; creates special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
  • Prepare budgets for research protocols and obtain research grants by preparing and writing protocol applications
  • Function as the administrator for all research assistants and research coordinators, temporary or permanent, when working on DMH projects
  • Provide oversight to DMH residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
  • Provide other duties that are within the scope of work
145

Clinical Research Parasitologist Resume Examples & Samples

  • Designs, implements and reports parasitology studies on ecto- and endo-parasites in both companion and food-producing animals
  • Serves as investigator as in-house parasitology studies for development drug candidates and label extensions of approved products
  • Ensures compliance with Good Clinical Practices (GCP) and occasionally Good Laboratory Practice (GLP)
  • Supports external parasitology studies, as needed
  • Maintains contact with the all stakeholders (project leader, RA, Quality Assurance (QA) etc. and keeps them informed of the study progress
  • Implements and manages a parasitology laboratory, including rearing and maintaining colonies of ectoparasites and gastrointestinal nematodes
  • Trains and manages laboratory technician(s)
  • Defines objectives, budgets, resources, timelines associated with the parasitology laboratory
  • Supports pre-development activities as required, including implementation of sensitivity assays, evaluation of formulations and dose characterization studies
  • Supports biological activities related to parasitology
  • Participates, as required, in meetings with management and/or regulatory agencies to present parasitology topics
  • Develops and maintains a network of clinical parasitology and scientific contacts
  • Minimum of (3) years of experience parasitology research, which may include graduate study in a relevant scientific field
  • Familiarity with MS Office programs
  • Familiarity with the principles of Good Clinical Practice and Good Laboratory Practice
146

Clinical Research Representative Resume Examples & Samples

  • Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes. Identifies and communicates important protocol and data management issues to appropriate sponsors
  • Recruits participants for research studies. Determines participant eligibility based on study specific criteria. Verifies that patients have completed appropriate registration materials and maintains related records and information. Obtains and reviews relevant medical history with participants
  • May serve as a backup, collecting and processing phlebotomy specimens for analysis using appropriate or specified equipment. Ensures proper labeling and obtains pertinent clinical and protocol information on request forms. Performs vital signs and EKG as appropriate
  • Trains other Research Assistants in scheduling and data entry systems and in clinical procedures such as EKG, vital signs and phlebotomy
147

Clinical Research Psychologist Resume Examples & Samples

  • Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to): organic mental disorders; psychotic disorders; schizophrenia; delusional disorders; mood disorders; anxiety disorders; somatoform disorders; psychoactive substance use disorders; sleep disorders; factitious disorders; impulse control disorders; psychological factors affecting physical condition; disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders; conditions not attributable to a mental disorder that are a focus of attention or treatment; sexual disorders; adjustment disorders; personality disorders; dissociative disorders; post-traumatic stress syndrome; etc
  • Provides diagnostic and therapeutic procedures (including but not limited to): interviewing; major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy; community outreach (e.g., health promotion and command consultation); mental status examination; crisis intervention; case management; medical discharge planning; psychosocial history taking; psychological test administration and interpretation; etc
  • Serve as an investigator on protocols related to human research. Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data
  • Write and prepare research applications, conduct literature searches for background information, conduct research, collect and analyze data, perform statistical analyses, perform scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
  • Retrieve, sort and collect data from hard copy and electronic databases. Collect and maintain data for ongoing research and academic protocols
  • Manage data processing applications, maintain hard copy and electronic files and be accountable for accurate and timely processing of all research data
  • Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft PowerPoint, and statistical software such as SPSS in order to analyze data and produce reports
  • Provide technical support for research studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
  • Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design. Maintain research packets for use by investigators
  • Receive and complete individual assignments from Staff and Residents, which involve specialized and/or short-term studies; identify information sources; collect, research and assemble background data; create special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
  • Function as the administrator for all research assistants and research coordinators, temporary or permanent
  • Provide oversight to Residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
  • Experience with Trauma Management Therapy similar to the therapy discussed in the following reference is preferred
  • Beidel, D. C., Frueh, B. C., Uhde, T. W., Wong, N., & Mentrikoski, J. M. (2011). Multicomponent behavioral treatment for chronic combat-related posttraumatic stress disorder: A randomized controlled trial. Journal of Anxiety Disorders, 25(2), 224-31. doi:10.1016/j.janxdis.2010.09.006
  • Knowledge of U.S. Navy; Naval Medical Center, Portsmouth; and/or Directorate of Mental Health policies and procedures is preferable, but not required
  • Knowledge of the Directorate of Mental Health functions in order to comprehend the scope of care and interactions of this directorate is preferable, but not required
148

Clinical Research RN Resume Examples & Samples

  • Education: Graduation from an accredited school of nursing
  • Experience: A minimum of 1 year of RN experience
  • 1 year of RN experience in research and/or oncology
  • Bachelor of Science in Nursing (BSN)
149

Associate Clinical Research Resume Examples & Samples

  • Ensures validity of study by identifying/resolving
  • A University degree is preferred or equivalent experience
  • Three to six years of related work experience is required
  • Strong verbal communication and interpersonal skills
  • A mechanical aptitude and good organizational skills
  • A keen interest in continuous learning
  • Experience running cartridges and dealing with blood is preferred
  • Science/Chemistry/Biochemistry and/or phlebotomy experience would be considered an asset
  • Personal attributes: professionalism , adaptability, approachability, enthusiasm, excellent attention to detail, self-motivated, shows initiative and can work effectively as part of a team
  • You must be a self-starter and have the ability to follow instructions and use good judgment. The individual must be flexible and be able to work in a fast paced environment with changing priorities
  • This position requires someone who can work Monday through Friday from 8:00 a.m. to 5:00 p.m
150

Clinical Research Coordinator, Certified Resume Examples & Samples

  • Recognizes, tracks and reports adverse events and protocol deviations
  • Represents the research program at meetings, national and international research consortia
  • Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
  • Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis
151

Experienced Clinical Research Associate Resume Examples & Samples

  • Note: The ideal candidate will reside within the region
  • Minimum of 1 year monitoring experience with a pharmaceutical company and/or CRO
  • Minimum of 1 year experience of monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc in the U.S.A
  • Proficient in the use of core trial management systems
152

Clinical Research Associate Trainee Resume Examples & Samples

  • If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA in tracking subject site recruitment progress
  • Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase
  • Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
  • Convey features and opportunities of study to site
  • Collaborate and liaise with study team members for project execution support as appropriate
  • Good written and verbal communication skills including good command of English language
153

Specialist, Clinical Research Resume Examples & Samples

  • Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
  • Edit/amend informed consent documents
  • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
154

Clinical Research Operations Manager Resume Examples & Samples

  • Provide leadership and oversight for clinical study operations world-wide
  • Establish mechanisms to track and report 3M’s global clinical research activities and impact
  • Ensure that OUS clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
  • Collaborate with division clinical managers to develop clinical studies to support division’s priorities and businesses
  • Bachelor's degree or higher from an accredited institution
  • Minimum of ten (10) years of pharmaceutical, medical device and/or academic health care experience
  • Minimum of ten (10) years pre-clinical and/or clinical research experience
  • Master’s degree or higher in a Science discipline from an accredited institution
  • Minimum of five (5) years of medical device experience
  • Experience with new product development programs
  • Proven process improvement experience such as Six Sigma
  • Strong communication skills and a demonstrated ability to work collaboratively with multiple functions and organizations
  • 3M experience working across multiple disciplines, businesses and/or departments (applies to internal applicants only)
155

Clinical Research Supervisor Resume Examples & Samples

  • Manage and develop a team of Clinical Research Professionals
  • Collaborate with the division and Clinical Managers to develop clinical studies to support division’s priorities and businesses
  • Establish mechanisms to track and report clinical research activities and impact
  • Ensure that clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
  • Propagate necessary policies and procedures to ensure compliance
  • Provide and facilitate clinical planning in support of business initiatives
  • Bachelor’s degree or higher from an accredited institution
  • Minimum of five (5) years combined experience working in a clinical research and/or technical environment
  • Bachelor’s degree or higher in Science, another health care discipline (e.g. MD/DO, RN, PharmD, MPH) or related discipline from an accredited institution
  • Minimum of five (5) years clinical trial management experience
  • Minimum of two (2) years supervisory experience
  • Certification, or willingness to obtain Association of Clinical Research Professionals (ACRP) Certified Clinical Research Accreditation (CCRA®)
  • Experience working with health economics studies
  • Demonstrated understanding of Good Clinical Practices (GCPs) and clinical trial regulations
  • Previous experience leading cross functional teams
  • Ability to influence across the Health Care Business
156

Clinical Research Associates Resume Examples & Samples

  • Unlike some CRA roles you will not be pushed to satisfy
  • All aspects of site management as prescribed in the project
  • Negotiation of study budgets with potential investigators and
157

Clinical Research Coordinator Associate Resume Examples & Samples

  • Excellent verbal and written communication skills in English and Spanish
  • Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience, with older adults who may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., Alzheimer’s disease)
  • Ability to communicate clearly and empathetically with research participants and their families
  • Strong interpersonal skills, including the ability to work easily with research participants and research team members
  • Strong general computer skills and ability to quickly learn and master computer programs
  • Proficiency with Microsoft Office and Excel
158

Clinical Research Protocol Analyst Resume Examples & Samples

  • Bachelor’s degree in relevant field such as biology, biomedical engineering, psychology, nursing, or public health
  • Advanced degree (PhD, PharmD, MPH) and/or clinical background (nursing or MD) preferred
  • Minimum 4 years experience in clinical research and/or patient recruitment
  • Experience interacting directly with patients in a research setting is a plus
  • Ability to analyze with strong attention to details
  • Persuasive writing skills and the ability to simplify complex medical concepts
  • Strong organizational skills and ability to perform multiple tasks
  • Ability to work independently, function effectively as a member of a team and adhere to strict deadlines
  • Ability and willingness to work collaboratively across multiple teams (Sales, Analytics, Proposals, Project management, IT, Media, etc.)
  • Strong working knowledge of (Word, Excel, PowerPoint) in a PC environment
  • Demonstrated comprehensive understanding of clinical research patient recruitment across multiple therapeutic areas
159

Assistant Site Clinical Research Associate Resume Examples & Samples

  • Supports the (Associate)/(Senior) ClinicalOperations Manager, Site Clinical Research Associates and any other clinicalresearch personnel involved, in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operation Procedures and applicable global, local and regulatory requirements and companyobjectives
  • The AssistantClinical Research Associate is key participant in the study startup activities and site openingactivities as well as study conduct and site closure tasks
  • May managethe activities of clinical Investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This positionmay assume independent site management responsibility in accordance with experience and performance
  • Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visitsfor Phase 1-4 studies in accordance with local regulations, Good Clinical Practices(GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and businessprocesses, if applicable
  • Conducts assigned clinical site activities and/or supports the (Sr.) SCRA in those according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
  • Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision
  • Manages the overallactivities of site personnel and motivate/influence them to meet study objectives, with appropriate supervision
  • Ensures qualityof data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
  • Ensures safety and protectionof study subjectsaccording to the monitoring plan, AbbVie SOPs, ICH Guidelines, and federal regulations
  • Appropriately escalates serious or outstanding issues to (Sr)/ (Associate) Clinical Operations Manager or the appropriate project team member(s)as defined in the study monitoring plan
  • Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.Reports monitoring activities and study site conductaccurately and completely. Prepare and submit written reports,both monitoring and administrative, with appropriate supervision. Keep management informedof study progress through periodic updates
  • Supports SCRAs with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required
  • Assists to conserve costs of departmental operation and control of travel expenses, with guidance from (Sr) Clinical Operations Manager
  • Assists in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements
  • Negotiates investigator/ hospital agreements with stakeholders. Maintainsand completes own expensereports as per local and applicable guidelines
  • Participates in departmental meetings
  • Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs
  • Gains knowledge and expertise acrossmulti-therapeutic areas throughclinical and scientificliterature review, ongoingawareness of industry practices and participation in professional activities
  • Undergoes and maintainstraining as requiredby Global ClinicalOperations and otherrelevant company procedures, to ensure adherenceto federal regulations, Good Clinical Practices (GCPs),ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
  • Appropriate life-science or healthcare-related qualification or experienceor equivalent work experience
  • Appropriate tertiary qualification, health related(e.g., Medical, Scientific, Nursing) preferred
  • One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trialsis preferred
  • Knowledge of conducting industry-sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelinesand applicable local regulations is preferred
  • Good planningand organizational skillsand the ability to work effectively and efficiently in a dynamicenvironment with competingprojects and deadlines
  • Good written and verbal communication skills.Written and verbal fluency in English and local language (if not English).Good observational skills,analytical and conceptual capabilities. Attention to detailand strong interpersonal skills
  • Ability to work, understand and follow work processes within the assigned function
160

Data Analyst, Clinical Research Resume Examples & Samples

  • Performs all data management activities for assigned studies, as appropriate
  • Protocol and Statistical Analysis Plan (SAP) review and input
  • Case Report Form (CRF) development and maintenance
  • Edit Check specifications development and maintenance
  • Data Management Plan development and maintenance
  • Data Quality Checks and discrepancy management
  • Analyzes data, identifies trends; prepares data tables for reports
  • Database setup testing and Edit Check programming testing
  • External data handling
  • Device reconciliation and tracking for investigational product
  • Participate in Post Market Surveillance reporting as appropriate
  • Additional study specific activities
  • Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
  • Communicates well with peers, study teams and management as appropriate to support studies and goals
  • Participates in efforts to improve Data Management processes, as needed/assigned
  • Represents the Data Management group at study team meetings
  • May represent the Data Management group on cross-functional task forces
  • May train and mentor other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs) on certain tasks
  • Applies best practices and established standards
  • Serves as a liaison between the study team and clinical data operations
  • Is a Subject Matter Expert (SME) in one or more areas within Data Management
  • Has a general understanding of the clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies
  • Communicates and collaborates with all levels of employees, customers, contractors, and vendors
  • Provides input to departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes
  • Performs other related duties and responsibilities, on occasion, as assigned
  • Typically a minimum of four plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes
  • Good organizational and project management skills, as well as attention to detail
  • Highly skilled with MS Office, especially Excel, Word, Publisher and Powerpoint
  • Strong ability to work with Clinical Data Management Systems
  • Understands databases; good technical skills in querying and analyzing data (SQL, Oracle, SAS or equivalent)
  • Certified Clinical Data Manager (CCDM) preferred
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Ability to travel approximately 10%
  • Ability to maintain regular and predictable attendance
  • Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent
161

MCI Clinical Research Coordinator Resume Examples & Samples

  • In lieu of degree, 7 years of oncology research or 9 years of research experience required
  • CITI Certification required
  • Must have broad experience in clinical trials
  • Clinical Research Coordinator Certification preferred
  • Computer literacy in Microsoft Office (MS Access, MS Word, and MS Excel) and Electronic Capture Platforms
  • Ability to manage multiple projects/protocols systematically and strong proofreading skills
  • Excellent interpersonal, collaborative, and team-building skills are required
  • Must be able to work in high-stress, high volume area and multi-task to ensure enrollment of patients in research protocols according to regulatory requirements
162

Clinical Research Coop Resume Examples & Samples

  • The general task and duties for this job is to collaborate with management, scientists, engineers, technicians, and test participants in order to design, execute, and complete projects
  • Work individually and in a team environment, includes cross-functional teams
  • Apply problem-solving skills to resolve scientific issues
  • Develop testing protocols; administer testing, analyzing and reporting the data
  • Ability to take initiative, think and work independently, problem-solve, work in teams and multitask; a solution orientated professional
  • This position actively participates in the execution and collection of research data of clinical investigations on Edgewell Personal Care products
  • The primary locations of this research will be at 50 & 60 Commerce Park, both in Milford CT
  • This position will help in designing, executing, analyzing and reporting the results of clinical investigations on Edgewell Personal Care products
  • This position executes clinical investigations of personal products, which may include direct contact with study participants to obtain measurements of skin properties
  • Facilitates clinical studies execution including preparing study documentation, supplies, labeling and dispensing test product, recruiting/scheduling/reporting panelist participation, and other study related responsibilities as needed
  • Supports other functions of The Institute of Evaluation Sciences or other Edgewell facilities as necessary
  • Junior or Senior studying Biology or Psychology with effective verbal and written communication skills
  • Ability to conduct statistical data analysis and its interpretation
  • Past work experience in industry
  • Experience with automated data collection systems
  • Owns a valid driver’s license
163

Clinical Research Financial Manager Resume Examples & Samples

  • Provides collaborative leadership and management oversight and coordination of special research projects for the NIAID, Division of Clinical Research (DCR), Office of Planning and Operations Support (OPOS)
  • Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate budget objectives
  • Serves as the primary interface for the budget management and planning of clinical research projects and other associated activities
  • Provides collaborative financial leadership and coordination of all budget components
  • Develops, maintains and tracks detailed site management budgets identifying applicable clinical research activities, tests, and other associated activities (e.g., subcontracts) to be performed during the conduct of a clinical research protocol
  • Ensures coordination and dissemination of information that would financially impact the clinical research projects by facilitating and maintaining strong communication channels among the many entities participating such as: NIH teams, investigators/colleagues, Leidos Biomed staff, subcontractors, etc
  • Works independently to assess complex financial requirements
  • Communicates with the CMRP Director, senior management, program staff and NIAID DCR project officials to provide consistent and accurate information
  • Participates in the financial execution of projects and provides technical guidance in the development of operational, technical and budget processes, templates, procedure manuals, and other documents
  • Prepares, monitors and analyzes financial forecasting, cost proposals, and reports
  • Monitors budget progress against complex project plans/key deliverables and provides monthly expense analyses
  • Manages budget risks by proactively anticipating issues and develops contingency plans and solutions
  • Conducts financial meetings and assists in the development of meeting agendas and summary reports as requested
  • Supervises staff
  • Possession of a Master’s degree from an accredited college/university in a field related to biomedical research/clinical trials/health or six (6) years related experience in lieu of degree
  • A minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing financial activities for protocols, site management and/or clinical research activities
  • In-depth knowledge of study design, clinical and bio-specimen terms used in research studies and scientific and medical concepts and terminology
  • Comprehensive knowledge of accounting theories, principles, procedures and methods, report analysis, contracting principles, provisions, reporting requirements and cash flow requirements
  • Excellent research and investigative skills with a high degree of accuracy and attention to detail
  • Extensive budgetary and strategic planning experience as it relates to clinical research
  • Ability to review complex documents independently and/or in collaboration with various stakeholders, and determine sufficiency of financial documentation
  • Experience in leading and developing team members
  • Must be detail-oriented, creative and flexible
  • Advance proficiency in Microsoft Excel, Word, and PowerPoint
  • Clinical Research or Project Management Professional with infectious disease experience
  • Experience in human subjects protection and clinical research activities
  • Familiarity with Federal Acquisition Regulations (FARs)
164

Clinical Research Coordinator Healthcare Resume Examples & Samples

  • Highly professional demeanor and positive attitude
  • Bachelor’s degree in related field required
  • 1 to 3 years of clinical research experience involving human subjects, IRB methodology, and working with a clinical research team
  • Must be able to multitask and prioritize effectively
  • Ability to work as part of a team or individually while meeting deadlines in a multitasking environment
  • Comfort with and proficiency in software applications used to support research processes (eResearch, etc)
  • Previous experience with MiChart, RedCap
  • Background in a medical field and knowledge of medical terminology
  • Flexible schedule is required, as some weekend (day) coverage may occasionally be required
165

Clinical Research Associate, Senior Resume Examples & Samples

  • Responsible for overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication
  • Contribute to protocol development and study related documents such as informed consent related to monitoring activities
  • Develop the monitoring plan for clinical studies
  • Ensure compliance to ICH/GCP/local regulations
  • Confirm and track that all key site personnel have project specific training
  • Responsible for study status reports, essential documents, and accurate study files
  • Assist with resolution of investigational site/data queries
  • Liaise with project team members regarding study site issues
  • Travel to study sites for meetings and monitoring visits upon request (ca. 40% travel of which 10% international)
  • Experience as a clinical research associate minimum of three years, five years preferred
  • Bachelor’s degree, in biological sciences or healthcare
  • Excellent interpersonal and organizational skills
  • A pro-active, committed and motivated attitude
  • Ability to work very accurate and thorough
  • Ability to work well in a team environment but also independently without significant oversight
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
166

Clinical Research Associate Respiratory Therapy Resume Examples & Samples

  • Work closely with R&D Engineers and Product Managers to provide in-depth clinical respiratory therapy knowledge in support of product development
  • Respond to questions from engineering regarding metrics, etc. pertaining to respiratory therapy guidelines
  • Perform research as needed to provide applicable information
  • Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
  • Identify issues that need resolution to ensure safety and effectiveness of the products
  • Participate in cross-functional meetings to provide clinical perspective and knowledge
  • Knowledge of how to, or a willingness to learn to, write protocols, reports, and other forms of research projects for various studies that Clinical Affairs is engaged in
167

Clinical Research Technician Resume Examples & Samples

  • Perform medical diagnostic tests such as electrocardiograms, blood pressure checks, glucose measurements, etc
  • Collect and process blood and urine samples per protocol requirements
  • Professionally interact with subjects, visitors, staff, and other healthcare professionals
  • Maintain nurse’s station inventory
  • Sanitize and stock treatment rooms and subject bedrooms
  • Dispose of and replace biohazard waste in lab and exam rooms per OSHA requirements
  • Perform administrative tasks as needed
  • Troubleshoot any study issues
  • Order and prepare lunch for subjects as needed
  • Other duties and responsibilities as assigned or directed
  • Ability to communicate in a clear and professional manner
  • Adhere to Good Clinical Practices (GCP)
  • Attention to detail and accuracy in completing tasks
  • EMT and BLS certification required
  • Paramedic and ACLS certification required
  • Registered Nurse degree required
168

Senior Associate, Clinical Research Resume Examples & Samples

  • Serve as a central contact for communications/correspondence between the Generic Product Development, Biopharmaceutics Group, and CROs and other vendors
  • Review the study protocols and if needed help to design data collection from known case report forms (CFRs)
  • Identify and assess the suitability of clinical and bioanalytical facilities for bioequivalence studies. Conducting general GCP and GLP audits
  • Maintain study schedules, request proposals/contracts from CROs, compare competiveness and work quality of the CROs, maintain study budgets, initiates CDAs with different vendors, process vendor contracts and ensures payments are sent on time to vendors
  • Monitor trials throughout their duration, which involves visiting the trial sites on a regular basis
  • Verify that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
  • Write visit and audit reports
  • Analyze and interpret scientific data using Phoenix WinNonlin and other databases
  • Generate and track drug shipments and ensure timely delivery of final clinical and bioanalytical reports for regulatory submissions
  • Ensure all unused trial supplies are accounted for and stored properly
  • Perform duties such as bulk copying and faxing, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents
  • Assist coordination of study logistics, documents, drug shipments, enrollment and safety 5%
  • Collect regulatory documents required for study initiation
  • Maintain central study files in a state of audit-readiness
  • Maintain reference products inventory list and order products when needed. Maintain reference products inventory list and order products when needed
  • Communicate regularly with Generic Products Development teams: provide information, track study randomization codes, reports, may follow up on problems identified during the study
  • Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, appropriate industry and Good Clinical Practices, Good Laboratory Practice and Applicable Regulatory Guidance standards
  • 8 years of experience with medical terminology, GCP, GLP and Pharmaceutical Industry Regulatory guidelines is required
  • 5+ years of demonstrated proficient with MS Office (Word, Excel, Access, and PowerPoint), email, internet, required
  • 2+ year of experience using computerized systems i.e., Phoenix WinNonlin, SAS, and other databases required
  • 2+ years of experience analyzing and interpreting scientific data and skilled use of computerized systems and databases required
  • 8 years work experience in clinical and bioanalytical science environment required
169

Clinical Research Coordinator Associate Resume Examples & Samples

  • BA/BS in Psychology, Public Health, Social Work or related social science field
  • Experience with social science research, ideally with children
  • Knowledge of University administrative systems
170

Clinical Research Coordinator Trauma & Critical Care Resume Examples & Samples

  • Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security
  • Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol#s data flow plan. Determine areas where data provenance may be compromised and develop solutions
  • Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
  • Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants,study, and institution
  • Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
  • Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research
171

Clinical Research Associate, Temporary Resume Examples & Samples

  • Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
  • Actively participate in the implementation and execution of clinical trial activities from study planning through closure
  • May perform site qualification, initiation, monitoring, and/or close out site visits
  • Develop and maintain tracking tools to support management of clinical studies
  • Participate in site budget negotiations
  • Assist in developing and managing study timelines
  • Plan and participate in Investigator meetings and CRA trainings
  • Assure regulatory compliance of investigational sites with SOP’s and FDA and ICH guidelines
  • Minimum of 3+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
  • Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc
  • Experience in protocol development/writing is preferred
  • Experience in international or global clinical trials is preferred
  • Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU directive, and other relevant, local regulatory requirements
  • Good knowledge of concepts of clinical research and drug development
  • Ability to travel up to 25% travel including ground and air required
172

Clinical Research Psychologist Resume Examples & Samples

  • Organic mental disorders
  • Psychotic disorders
  • Schizophrenia
  • Delusional disorders
  • Mood disorders
  • Anxiety disorders
  • Somatoform disorders
  • Psychoactive substance use disorders
  • Sleep disorders
  • Factitious disorders
  • Impulse control disorders
  • Psychological factors affecting physical condition
  • Disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders
  • Conditions not attributable to a mental disorder that are a focus of attention or treatment
  • Sexual disorders
  • Adjustment disorders
  • Personality disorders
  • Dissociative disorders
  • Post-traumatic stress syndrome
  • Provides diagnostic and therapeutic procedures (including but not limited to)
  • Interviewing
  • Major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy
  • Community outreach (e.g., health promotion and command consultation)
  • Mental status examination
  • Crisis intervention
  • Case management
  • Medical discharge planning
  • Psychosocial history taking
  • Psychological test administration and interpretation
  • Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data in the DMH
  • Write and prepare research applications, conducts literature searches for background information, conducts research, collects and analyzes data, performs statistical analyses, performs scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
  • Possess a doctoral degree in clinical or counseling psychology
  • Possess a valid, unrestricted license or certification to practice as a psychologist in any one of the 50 States, the District of Columbia, the Commonwealth or Puerto Rico, Guam or the U.S. Virgin Islands
  • Experience with Trauma Management Therapy similar to the therapy discussed in the following reference preferred
  • Complete MTF provided human