Clinical Research Coordinator Resume Samples

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M Bruen
Madisyn
Bruen
41690 Wilderman Dam
New York
NY
+1 (555) 346 7595
41690 Wilderman Dam
New York
NY
Phone
p +1 (555) 346 7595
Experience Experience
New York, NY
Clinical Research Coordinator
New York, NY
Rau-Rau
New York, NY
Clinical Research Coordinator
  • Works with Program Manager and PI to prepare study reports and assists with drafting grant applications
  • Assists Management with Business Development efforts
  • Participate in quality and process improvement efforts to create and maintain a high-performing and efficient team
  • Developing simple user interfaces for data entry, workflow management and querying
  • Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care
  • Provides guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assists in training new personnel
  • Creates and processes paperwork necessary for purchase orders, check requests, travel reimbursement etc. Tracks all expenditures and reconciles with funds
present
Houston, TX
Clinical Research Coordinator
Houston, TX
Reynolds Inc
present
Houston, TX
Clinical Research Coordinator
present
  • Data Management. Performs or assists in data entry, management, and data analysis
  • Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality
  • Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality
  • Additionally assist with data management related activities in the network
  • Assist in the development and coordination of program-related events and workshops for patients with metastatic breast cancer
  • Assist with the development and management of research subcontracts
  • Works with department supervisor/manager to assist and train new hires in the research department/across all specialties
Education Education
Bachelor’s Degree in Basic Sciences
Bachelor’s Degree in Basic Sciences
University of Memphis
Bachelor’s Degree in Basic Sciences
Skills Skills
  • Knowledge of and ability to adhere to good clinical practices (GCP)
  • Excellent organizational skills and attention to detail in maintaining accurate, retrievable records
  • Excellent attention to detail and ability to interpret and master complex research protocol information
  • Ability to attend to detail and be precise with the ability to work independently, exercising judgment in establishing priorities
  • Demonstrated strong attention to detail and ability to adhere to project deadlines
  • Strong analytical skills and the ability to resolve technical or research problems and issues, and to interpret the acceptability of data results
  • Strong working knowledge of good clinical practice (GCP)
  • Ability to prioritize quickly and appropriately
  • Completion of a Certified Clinical Research Coordinator (CCRC) training program or equivalent is highly desirable
  • Strong ability to multi-task
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15 Clinical Research Coordinator resume templates

1

Clinical Research Coordinator Resume Examples & Samples

  • Creating new protocols, consents, and accompanying documents with investigators
  • Navigating a protocol with an interdisciplinary team
  • Obtaining consent
  • Managing regulatory binders
  • Managing study conduct throughout the study providing subject care as appropriate
  • Creating study specific source documents and CRF's
  • Establishing protocol specific classes for the staff
  • 2-6 years of clinical nursing experience
  • New York State Registered Nurse license
  • High proficiency in Microsoft Word, Excel and other databases
  • Bachelor's degree in Nursing
  • Proactive professional who is ready to get their hands dirty
  • Educational emphasis in clinical research and/or nursing
2

Clinical Research Coordinator Resume Examples & Samples

  • Experience in Cardiology Clinical Research
  • Prior cardiovascular experience
  • Knowledge of Microsoft Office
  • Registered Nurse or Physician Assistant license
3

Clinical Research Coordinator Resume Examples & Samples

  • Plans, organizes and schedules assessments/tests/activities to meet research objectives and study protocol compliance. Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocol. Serves as contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor
  • Prepares and submits timely, accurate, and complete documentation of study continuing review and study amendments to Institutional Review Board (IRB). Assists investigators with reportable event submissions to IRB
  • Assists with preparation of study documents such as informed consent, recruitment script, and other materials. Assists with preparation of proposal, protocol, case report forms and progress notes, as needed. Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies
  • Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject’s willingness to participate in a study, when needed. Evaluates subject compliance and promotes compliance through education. Coordinates in-service classes for nurses, pharmacists and others regarding the study and/or investigational product
  • Prepares site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors
  • Coordinates sample collection, processing and shipment for each study
  • Arranges and attends meetings, seminars, symposia and other events related to project efforts. Participates in educational opportunities to increase knowledge about clinical trials and regulations. Remains current with federal, state, and institutional regulations and best practices
  • Completes Research Order Form (ROF) for each subject visit and submits subject enrollment documentation as required
4

Clinical Research Coordinator Resume Examples & Samples

  • Assists with data collection for research studies following established data collection and management procedures. Collects, records, enters and prepares data for analysis. Performs preliminary study analysis under the direction of the Principal Investigator or senior coordinators. Collects pertinent information from study participants through interviews, administration of tests or surveys or questionnaires, medical records review, or other collection procedures
  • Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies
  • Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject’s willingness to participate in a study, when needed. Evaluates subject compliance and promotes compliance through education
  • Assists in the preparation of site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors
  • Updates automated databases and other records for reporting and compliance purposes. Generates reports and analysis of data according to project schedules or on an ad hoc basis
  • Assists by arranging and attending meetings, seminars, symposia and other events related to project efforts. Participates in educational opportunities to increase knowledge about clinical trials and regulations. Remains current with federal, state, and institutional regulations and best practices
5

Clinical Research Coordinator 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
  • Assists the Clinical Research Coordinators in protocol assessments, planning activities and coordinating multiple research studies
  • Assists the Clinical Research Coordinators in preparing and submitting documents to institutional review board
  • Attends and participates in investigator meetings as directed
  • Participates in subject / patient recruitment and evaluation of eligibility
  • Collaborates with the senior level clinical research coordinators to review and verify required source documents in subject's medical record to confirm study eligibility
  • Reviews inclusion / exclusion criteria with investigator and department NP / PA / RN to assure subject eligibility
  • Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
  • Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately
  • Maintains patient screening enrollment logs
  • Conducts screening, eligibility and enrollment procedures as directed
  • Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects
  • Follows randomization procedures and dispenses study drugs per protocol
  • Reviews diaries and questionnaires completed by subject as appropriate
  • Performs phlebotomy functions (if licensed to do so) as indicated by the study protocol
  • Ensures appropriate specimen collection, batching and shipping as required
  • Schedules subjects for follow-up visits
  • Assesses subject compliance with the test drug on follow-up visits
  • Collects and documents adverse event information for evaluation by the investigator and department NP / PA / RN
  • Protects subject confidentiality
  • Protects patient privacy during initial and follow-up interviews and visits
  • Secures safe storage of study-related documents
  • Assures appropriate disposal of sensitive documents
  • Documents and maintains all study-related procedures, processes and events
  • Documents protocol deviations and exemptions and assists with quality assurance
  • Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results)
  • Records accurate and timely data onto case report forms
  • Maintains source documentation for all case report entries
  • Transmits data via fax, mail or electronically as requested by sponsor or CRO
  • Resolves data queries
  • Completes and maintains all study drug accountability records including drug dispensing drug
  • Reviews returned drugs for compliance and documents findings
  • Maintains files for all study-related documentation
  • Communicates effectively with subjects, research team, IRB's and sponsors
  • Provides subjects with information about reporting study-related events to research team
  • Follows the mechanism established to contact subjects for follow-up visits and new information
  • Utilizes a phone log to document telephone communications
  • Meets regularly with investigator and research team to discuss subject participation and protocol progress
  • Submits protocol amendments and progress report to IRB as directed
  • Notifies the investigator, sponsor and IRB timely of adverse events as outlined in the protocol, as directed
6

Clinical Research Coordinator Resume Examples & Samples

  • Minimum of an RN license required
  • Two years in a clinical research setting, preferably working as a clinical research coordinator on Industry-Sponsored clinical trials
  • Urology experience preferred
  • Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
  • Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
  • Familiarity with the Microsoft Office Suite
  • Previous work with CRFs and EDC
  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
  • Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians
  • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
  • Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study
  • Develops clinical study budgets based on proposed study protocols
  • Coordinates approval of new study agreements and contracts
  • Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits
  • Completes case report forms. Extracts data from patient charts in a timely manner
  • Responds to data clarification requests in a timely manner
  • May attend Investigator meetings requiring travel and report pertinent information back to research team members
  • Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, BFS and sponsoring agency policies and procedures
  • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training
  • Maintains subject screening logs and protocol deviation logs
  • Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials
  • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors
  • Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations
  • Cooperates with sponsoring agency's compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office
  • Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis
  • Ensures that all materials for each clinical trial protocol are available for subject enrollment
  • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data
  • Performs specimen processing and shipment of biological specimen duties
  • Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
  • Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required
  • Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures
  • Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research
7

Clinical Research Coordinator Resume Examples & Samples

  • Provides overall management and execution of the studies in the geographic area
  • Demonstrate good clinical practices (GCP) and ensure study teams comply with GCP
  • Helps project team to overcome organizational obstacles
  • Accountable for the success of the studies, assists in selection and placement of clinical trials
  • Facilitates the team process
  • Acts as a liaison between the physicians, sponsors and TM's
  • A deliverable revenue/EBITDA goal for each budget year
  • Mentor and build the capacity of village TM's to assist in the conduct of clinical trials
8

Clinical Research Coordinator Resume Examples & Samples

  • Perform subject interviews and assessments (i.e. adverse events and concomitant medications) at study visits for data required by protocol
  • Screen and identify potential subjects from review of protected health information based on protocol eligibility criteria
  • Evaluate protocol, determine staff, facility, and subject population availability
  • Monitor study team compliance with required study procedures and GCP standards
  • Extract data from source documents, complete case report forms, resolve sponsor queries -Review subject SAE information and assist PI in submission and/or determination of SAE
9

Clinical Research Coordinator Resume Examples & Samples

  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required
  • Early Intervention (E.I.) credentialed
  • 1 year research study experience
10

Clinical Research Coordinator Resume Examples & Samples

  • Experience with scheduling complex clinical research visits, both inpatient and outpatient, up to one-week in length, with patients of all ages who have complicated, rare, and long-term conditions
  • Experience collecting biological samples including (but not limited to) blood and urine
  • Experience coordinating with clinical staff for additional clinical or research procedures and sample collections such as ECG, EEGs, imaging, radiology, skin/tissue biopsies
  • Experience and comfort working with large, multidisciplinary teams – almost all disciplines of medicine are to be encountered over time, but especially Neurology, Medical Genetics, Cardiology, Rheumatology, Immunology, Gastroenterology, and Dermatology
  • Ability and motivation to learn quickly and problem solve as required for each unique case
  • Experience and comfort with medical terminologies
  • Knowledge and interest of genetic conditions and the implications to families
  • Familiarity of federal and local laws pertaining to genetic discrimination and patient privacy
  • Advanced use of REDCap Database systems, particularly the ability to design and/or maintain large, complex projects
  • Experience working with very sick children and their parents
  • Team-oriented, enthusiastic, and patient friendly – this position is a point person for patient contact and experience
  • Up-to-date documented knowledge of federal research and clinical regulations (CITI, HIPAA, & GCP certifications; note, external applicants would be required to update training to Stanford requirements)
  • California phlebotomy licensure desired
  • Interest in contributing to publications, posters, and abstracts a plus
  • Advanced degree encouraged though specifically not required if the above are adequately met (e.g. MS, RN, CGC)
  • Three-five years or more experience desired
11

Clinical Research Coordinator Resume Examples & Samples

  • Experience using Electroencephalography (EEG) in individuals with autism and/or developmental disabilities
  • Experience in clinical research, particularly with children
  • Experience with SPSS, Excel and REDCap
12

Clinical Research Coordinator Resume Examples & Samples

  • Experience/knowledge of Anesthesia clinical trials
  • Experience/knowledge of clinical trials including recruitment and informed consent
  • Minimum of one year related experience
13

Clinical Research Coordinator Resume Examples & Samples

  • 2-4 years of clinical research coordination experience; bilingual (English/Spanish) preferred
  • Demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment
  • Ability to work effectively with a wide range of individuals at all levels of authority
  • A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, and exercise sound judgement in setting priorities
14

Clinical Research Coordinator Resume Examples & Samples

  • Experience with University research policies and procedures
  • Candidates must possess strong organizational skills and a demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment
  • 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
  • Excellent communication and problem-solving skills
  • Experience in CV is desired
15

Clinical Research Coordinator Resume Examples & Samples

  • Experience with research protocols and regulatory of governing bodies, which includes, HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
  • May have experience with research protocols and regulatory of governing bodies, which includes, HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
  • Experience with statistical analysis software, such as SAS
  • Proficiency with Microsoft Office (especially Excel), REDCap and electronic data capture database applications
  • Familiarity with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices
  • Demonstrate sound judgement and problem-solving skills that will protect volunteer safety and promote highest standard of clinical trial compliance
16

Clinical Research Coordinator Resume Examples & Samples

  • Ability to organize work and multi-task
  • Ability to produce timely and accurate reports to monitor regulatory and clinical processes
  • Proficiency in Microsoft Office (especially Excel), REDCap and electronic database capture applications
  • Extensive experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
  • Practical knowledge and experience with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices
17

Clinical Research Coordinator Resume Examples & Samples

  • As one of the main studies is in the East Asian population, bilingual in Mandarin, Korean or Japanese preferred
  • Must have excellent communication skills on phone and in person
  • Must have prior clinical research experience or coursework
18

Clinical Research Coordinator Resume Examples & Samples

  • Master's degree in public health or statistics is preferred
  • Proficiency with Word and Excel for data management
  • Experience with data management, internet research, manuscript preparation
  • Experience with data analysis and ideally, familiarity with statistical programs (e.g. SPSS, STATA, R, and/or SAS)
  • Proficiency in Microsoft Office, Excel, and database applications
19

Clinical Research Coordinator Resume Examples & Samples

  • Two or more years related experience preferred
  • Knowledge of ethical principles and federal and state regulations governing the participation of human subjects in biomedical research
  • Excellent interpersonal and oral communication skills to effectively work with other research and administrative support staff
  • Experience with research protocols and regulatory bodies, including HIPAA regulations, Institutional Review Board requirements and Good Clinical Practices
  • Ability to work both independently and as part of a multidisciplinary team
  • Ability to determine workload priorities in an appropriate way to accomplish tasks and goals, meet deadlines, and anticipate and solve potential problems
  • Good oral and written communications kills to effectively work with physicians, clinical staff and other health care professionals
20

Clinical Research Coordinator Resume Examples & Samples

  • Follow plans and standard operating procedures under the guidance of study leadership to recruit, enroll, consent, collect data, and retain participants
  • Collaborate effectively with others to ensure proper progress & completion of studies
  • On a periodic basis, adjust regular working schedule to provide weekend enrollment coverage as needed
  • Implement successful plan in line with approved protocol to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
  • Following standard operating procedures, participate directly in recruitment/enrollment
  • Communicate with participants and families in culturally sensitive manner
  • Communicate study-related issues to investigators, study coordinators, clinical team, managers and other institutions in a timely fashion
  • Perform data entry and validation to ensure accuracy, quality and compliance of data collection process
  • Bachelor’s degree in a field appropriate to the area of assignment AND two years related research experience; OR,
  • Six years research experience appropriate to the area of assignment
  • Previous human subjects training (e.g., CITI certification) and two years’ experience as a research coordinator with direct recruitment and enrollment responsibilities
  • Phlebotomy training and experience
  • Strong organization skills and significant attention to detail for data entry
  • High level of integrity, ethics and professionalism
21

Clinical Research Coordinator Resume Examples & Samples

  • Bachelor’s Degree in Health Education, Social Work, Nursing, Medicine or Public Health
  • Experience in Program Management and 1-3 years supervision required
  • Ability to maintain interpersonal relationships and utilize proper channels of communication
  • Ability to maintain confidentiality of information
  • Ability to work independently but function as integral member of the team
  • Reliable transportation, driver’s license and proof of auto insurance required. Must be able to use own transportation to travel to training programs throughout the state of Ohio. Will be reimbursed University mileage reimbursement rate for travel to and from training programs off site at the current rate per mile
  • Some overnight travel required with meal and lodging per diem per policy
  • Proficiency in use of Microsoft word, PowerPoint and Excel
  • Willingness to complete necessary/required training for job specific duties
  • Basic knowledge of HIV
  • Experience as a trainer, education or practice transformation coach
22

Clinical Research Coordinator Resume Examples & Samples

  • Plan and coordinate research projects
  • Coordinate the generation of support data for manuscripts and proposals
  • May assist in developing reports
  • Assist with modifications of protocols
  • Perform related duties based on departmental need
23

Clinical Research Coordinator Resume Examples & Samples

  • Collaborates with CTRC and 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, and protocol specific tests and procedures
  • May be called upon to perform the following specific tests and procedures: A) blood pressure, pulse, height, weight, and temperature measurements, b) specimen processing and shipping, c) pulse oximetry
  • Experience: One year of research coordinator experience
  • 1 or more years’ experience in support of cardiology clinical trials (interventional cardiology & imaging research, electrophysiology, and heart failure)
  • Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials
  • Experience working with physicians and nurses in clinical research
  • Knowledge of Good Clinical Practice (GCP)/ICH guidelines in clinical research
  • Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
  • Ability to work both independently upon training and part of a multi-disciplinary team
  • Ability to operationalize written protocols
  • Must be able to work under pressure in a deadline oriented environment
24

Clinical Research Coordinator Resume Examples & Samples

  • Four (4) years of general clerical or administrative service experience, which includes one (1) year of experience working in an academic research or related environment
  • Bachelor's degree from an accredited college or university in a related field
  • Three (3) or more years' of experience working in a research environment
  • Experience communicating with industry sponsors
  • Experience with clinical trial budgeting and negotiation
  • Experience in the conduct or oversight of clinical research studies
  • Certified Clinical Research Professional (CCRP)
  • Experience routing contracts through central grants and contracts office
  • Demonstrated ability to work effectively with a diverse population of faculty, staff and students
  • Excellent knowledge regarding clinical research regulations and principals of ethical conduct
  • Knowledge, experience, and ability to manage complex information and computer systems
  • Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders
25

Clinical Research Coordinator Resume Examples & Samples

  • Bachelor Degree in any field
  • Two (2) years of clinical and/or research experience required
  • Bachelor’s degree in a science or health related field
  • Oncology Clinical Research experience
  • Excellent attention to detail and ability to interpret and master complex research protocol information
26

Clinical Research Coordinator Resume Examples & Samples

  • This position is for the research study therapist role on a clinical research intervention trial of smoking cessation and depression. The position requires a therapist, counselor, or clinical social worker to administer the study's protocol for smoking cessation, working with individuals with depression. The intervention involves two different behavioral therapy protocols, administering psychiatric diagnostic interviews, and addressing medication adherence
  • Please submit a cover letter for full consideration
  • Successful completion of a full 4-year course of study in a social or health science from an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience
  • 2 years' experience; or 4 years’ practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required
  • A master's degree in clinical psychology, counseling psychology, or clinical social work, or related field or the equivalent combination of education, training and experience from which comparable skills can be acquired
27

Clinical Research Coordinator Resume Examples & Samples

  • Please note: Some travel required throughout the year to attend investigator meetings or other study conferences. These meetings are not typically held within the immediate Chicago metropolitan area
  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a social or health science + 2 years’ experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required. OR appropriate combination of education and experience
  • Ability to become certified as a study coordinator within two years of employment in the department
28

Clinical Research Coordinator Resume Examples & Samples

  • One year in health-care or health-care research
  • Knowledge of the principles of clinical research and federal regulations. Good understanding of how information is collected in clinical settings
  • Excellent written and oral communications skills; must be comfortable presenting complex material to a variety of audiences
  • Must be computer literate and able to learn to use unfamiliar applications quickly
  • Exceptional organizational skills and the ability to perform many tasks simultaneously and independently
  • Previous experience as an educator to other health care professionals
29

Clinical Research Coordinator Resume Examples & Samples

  • 3-5 years experience
  • Prior critical care nursing experience
  • Experience with developing and conducting clinical trials including site monitoring strategies and risk mitigation
  • REDCap database management
30

Clinical Research Coordinator Resume Examples & Samples

  • Orients and assists in training new staff
  • Bachelor's Degree required and at least 1-3 years of equivalent experience required. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed
  • Excellent organization and communications skills required. Strong interpersonal skills - ability to effectively interact with all levels of staff and externals contacts. Must be detail oriented and have the ability to follow-through. Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times. Must have computer skills including the use of Microsoft Office
  • Proficient in understanding of phases of clinical trials
  • Ability to coordinate PI initiated studies
31

Clinical Research Coordinator Resume Examples & Samples

  • Serve as the study coordinator for a few longitudinal clinical research studies
  • Screen, recruit, and enroll eligible patients and track participation over time
  • Conduct face-to-face interviews with patients and discuss topics that include: prognostic understanding, treatment preferences, end-of-life care, clinical symptoms, and quality of life
  • Coordinate with oncology providers and research staff in the gynecologic oncology clinic to recruit and enroll patients
  • Prepare reports that provide current snapshots of a study’s data, participation, and progress
  • Report study progress to the Gynecologic Oncology Clinical Research Team during weekly meetings and meet one-on-one with the clinical investigator
  • Perform preliminary quantitative and qualitative analyses of study data
  • Review and abstract health information from patients’ electronic medical records
  • Maintain patient charts and study databases and ensure data is complete and accurate
  • Support the development and submission of publications, presentations, reports, and other study-related documents
  • Enter data and perform literature searches, administrative duties, and additional tasks as needed
  • BA or BS degree required, with 0-2 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred
  • Interest in academic research, medicine, health care, or public health
  • Capable of discussing personal topics with patients in a compassionate, sensitive manner
  • Must be detail oriented, have the ability to follow-through, and have strong problem-solving skills. Proficiency in Microsoft Excel, Word, and PowerPoint and willingness to learn RedCap and other technologies as necessary
  • Reliable, self-motivated, and able to prioritize tasks and meet deadlines
  • Post-undergraduate experience a plus
32

Clinical Research Coordinator Resume Examples & Samples

  • Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities
  • Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required
  • Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed
  • Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases
  • Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process
  • Serves as a liaison to other departments and programmatic areas, as well as community agencies
  • Ensures that primary referring physicians receive timely progress notes on the patients diagnosis and treatment
  • May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner
33

Clinical Research Coordinator Resume Examples & Samples

  • Associate's Degree required
  • Oncology research background preferred
  • Background in research methodology, preferred
  • Must be able to work with latex products
34

Clinical Research Coordinator Resume Examples & Samples

  • Under the direction and supervision of the Clinical Research Department Manager, provide administrative support for variety of industry-sponsored and investigator-initiated studies including development and maintenance of Allegro and EPIC study visits and billing calendars; maintain accurate and current information of EHR and database management system, per study protocols and budget and Sutter Health approved procedures
  • Follow up with Clinical Research Department colleagues, Research Institute and Sutter centralized Research Administration staff, study subjects, physicians and other providers on a variety of key activities related to study protocols and/or department activities, as required
  • Under the close guidance of the Clinical Research Department Manager, provide assistance in the submission of protocols to the Sutter Health Institutional Review Board
  • Other duties, as required by department, Sutter Research Enterprise, PAMFRI and/or Sutter Health
  • 1+ years working in a team-based environment; demonstrated keen attention to detail; proven ability to multi-task; high degree of comfort in Ability to work in fast-paced environment in which priorities can change frequently; ability to collaborate successfully with multiple constituents who represent specific areas of expertise and are passionate about very fast turnarounds and high levels of responsiveness
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Clinical Research Coordinator Resume Examples & Samples

  • Certified Medical Assistant or Licensed Practical Nurse with current credentials to practice in the state of Ohio
  • Demonstrated proficiency in venipuncture or willingness to be trained in venipuncture with successful completion of training within 3 months
  • Twelve months health care experience
  • Infectious Diseases experience strongly preferred but not required
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Clinical Research Coordinator Resume Examples & Samples

  • A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required. Bachelor with certification as ALAT, LAT or LATG with AALAS may be given preference during the technical evaluation
  • A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification may be given preference during the technical evaluation
  • Working knowledge of PHS, OLAW, AWA, USDA, Guide and AAALAC
  • Working knowledge of IACUC rules and regulations
  • Experience with submission of protocol amendments
  • Experience with exotics, small animal ruminants, and large animal models
  • Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements
  • Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings
  • Skills in counseling, guidance, and maintaining interpersonal relationships
  • Good typing skills to allow online documentation of patient interactions
  • Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, and be adept at prioritizing and multitasking. Must be comfortable with changing conditions and research workload
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Clinical Research Coordinator Resume Examples & Samples

  • A Bachelors Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Masters Degree or certification as a Registered Nurse will be given preference
  • A minimum of two years ofexperience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI); Certified Clinical Research Coordinator (CCRC); or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
  • Skills in counseling; guidance; and maintaining interpersonal relationships
  • Good typing skills to allow online documentation of patient interactions. Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
  • Work requires concentration; periods of standing and walking on a regular basis. Must work well under pressure; often changing conditions and research workload
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Clinical Research Coordinator Resume Examples & Samples

  • Responsible for coordinating the research activities of assigned basic science, IRB and Institutional Animal Care and Use Committee (IACUC)-approved study protocols. Protocols will include both pediatric and adult patients, animals and human anatomical specimens (including cadavers)
  • Accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness
  • Proficient in appointment booking, appointing referrals, documenting Telephone Consults and other patient interactions, coordinate laboratory studies, x-rays, and other tests. Personnel must be proficient in the use of clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
  • Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the Principal Investigator for final evaluation. Returns telephone calls from research participants in an efficient and timely manner and documents interactions appropriately
  • Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented. Conduct telephone, face-to-face interviews or mail information for follow-up visits
  • In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol and maintain accurate documentation record of drugs received
  • Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator
  • Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol
  • Process and prepare specimens for lab analysis and shipping. Observe universal precautions and OSHA standards when processing or handling specimens
  • Collect clinical data in a timely and accurate manner and submit information to coordinating centers as required. Assist with data collection in animal and bioskills laboratory as needed
  • Report adverse events to governing agencies and sponsors as required by protocol and regulations
  • Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Principal Investigator’s File Binder/Regulatory Binder
  • Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol
  • Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency
  • Provide other administrative duties that are within the scope of work
  • Completed human protection training developed by the Collaborative Institutional Training Initiative (CITI)
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Clinical Research Coordinator Resume Examples & Samples

  • Clinical Research Project Plan and Preparation
  • Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate
  • Provides accurate and timely project status updates to Project Managers and sponsor
  • Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals
  • Accommodates flexible schedule (available days, afternoons, nights, and weekends)
40

Clinical Research Coordinator Resume Examples & Samples

  • Clinic logistics planning, schedule of clinic activities, and team training
  • Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules
  • In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
  • Confirms all required regulatory and contractual documentation is present prior to study start
  • Clinical Conduct
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Clinical Research Coordinator Resume Examples & Samples

  • Recruits and evaluates potential study subjects. Per protocol instruction, conducts telephone interviews or schedules patient for study visit and screening. May be required to perform clinical tests such as phlebotomy, EKGs, neurocognative tests, etc
  • Interacts with subjects with regard to study, including subject education, procedural instruction, follow-up. May serve as a liaison between subject and other research staff including the sponsor, IRB, study PI and clinical trials project manager
  • Responsible for collecting data and maintaining patient information database for study. May be required to input data, do minimum analysis and run various reports. Maintains subjects records as part of record keeping function
  • Ensure compliance with the Partners IRB, Dana-Farber’s IRB and other federal and institutional guidelines. Assists with research billing and study fund maintenance on assigned clinical trials
  • Responsible for coordinating study start up procedures and addressing logistical concerns brought up by pharmacy, radiology, industry sponsors, billing compliance and other collaborating departments like neurology, neuro-oncology
  • Maintains inventory and orders supplies when necessary
  • Position may require some on-call work
  • Position may require some domestic travel
  • New graduate with relevant course or project work
  • Prior experience working in translational or clinical research preferred, but not required
  • Experience working in a healthcare setting preferred
  • Available for some on-call work if required by clinical trials
  • Available for minimal domestic travel to other Partners Institutes
  • Experience with Power Point, Excel and other Microsoft office programs
  • Please include a cover letter noting any plans for school applications (strongly preferred)
  • Knowledge of computer programs, databases, etc
42

Clinical Research Coordinator Resume Examples & Samples

  • Previous experience with working with families and children with autism
  • Research experience
  • Demonstrated success in following through and completing routine tasks
43

Clinical Research Coordinator Resume Examples & Samples

  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience
  • Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
  • Highly proficient with Microsoft Office suite (Word, Excel, PowerPoint, Outlook)
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Clinical Research Coordinator Resume Examples & Samples

  • Assist in prospective collection of data on intubated patients for the purpose to be entered into the NEAR registry
  • Collect all forms weekly and enter electronically into the NEAR web‐based data management tool
  • Retrieve the patient medical record number in StudyTRAX to retrospectively identify and input missing data from the patient’s Emergency Department (AHLTA) chart
  • Bachelor degree in scientific or health care field
  • A minimum of five (5) years of experience in clinical research and research design with familiarity in medical terminology and common medical abbreviations
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Clinical Research Coordinator Resume Examples & Samples

  • 3 years of experience in clinical research
  • Advanced degree in Health/Medical field
  • Fluent in both writing and/or speaking Spanish strongly preferred
  • Knowledge of how to interpret sponsor agreements strongly preferred
  • Strong background in clinical trials research, including protocol design; recruitment and screening of potential participants; identification and communication of adverse health effects
  • Must have the ability to directly coordinate clinical trials within a clinical research setting; demonstrated ability to work effectively within a moderately autonomous environment, in addition to having a complete commitment to achieving goals
  • Must be flexible, dependable & able to handle multiple priorities with conflicting deadlines
  • This position has a need for flexible work hours, which may involve day or nighttime coverage. There is the possibility that the shifts may change based on the research needs of the division
46

Clinical Research Coordinator Resume Examples & Samples

  • For consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc
  • Work with the PI to develop and implement recruitment strategies in accordance with IRB/HRPO requirements and approvals
  • Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible subjects to the PI for final evaluation, enrollment, and randomization per protocol design
  • Ensure the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented
  • In collaboration with the research pharmacist, ensure correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability
  • Ensure subjects receive education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable
  • Ensure adequate inventory of study supplies, including drugs, devices, etc
  • Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs
  • Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the execution of a study related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Train appropriate personnel as needed. Maintain documentation of training
  • Coordinate the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol
  • Observe universal precautions and OSHA standards when handling specimens
  • Obtain laboratory results and consult with the PI for follow-up care as per protocol
  • Collect data in a timely and accurate manner and submit information to coordinating centers as required
  • Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations
  • Evaluate compliance of research subject and complete documentation of status and progress
  • Respond to compliance Officer audit findings and, after consultation with PI, implement approved recommendations
  • Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol
  • Maintain detailed documentation of the research study including but not limited to subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder
  • Interact on a regular basis with the PI and study team members regarding the conduct of the research study
  • Attend conferences and other meetings as required by the protocol, the PI, or sponsoring agency
  • Return telephone calls from research participants in an efficient and timely manner and documents interactions appropriately
  • Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons
  • Assist the compliance Officer with monitoring process to ensure protocol compliance
  • Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols
  • Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency as authorized by contract
  • Perform other research related duties as needed
  • A minimum of two years’ experience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
  • Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date and additional protocol specific training as required
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Clinical Research Coordinator Resume Examples & Samples

  • Collaborate with the Site Manager and other staff members to prepare for and execute assigned studies
  • Assist in ensuring that study objectives are met on time, within budget and according to applicable regulations and quality standards
  • Captain/lead studies, including
  • Review study protocols, case report forms (CRF), other study documents, and electronic data capture systems
  • Attend all relevant study meetings
  • Collect and submit regulatory/ethics documentation
  • Recruit and screen patients for trials and maintain patient screening log
  • Orient patients to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
  • Design and maintain source documentation based on protocol requirements
  • Schedule and execute study visits and perform study procedures
  • Collect, record and maintain patient study data according to study protocol and SOPs, ensuring quality control for content, accuracy and completeness
  • Handle labs, including preparation of specimen collection tubes and lab logistics
  • Monitor patient safety and report adverse reactions to appropriate medical personnel
  • Correspond with patients and troubleshoot issues on study
  • Participate in huddles to ensure daily tasks are assigned to team members and are executed to the expected standards
  • Assist with data quality checking and query resolution
  • Perform a variety of complex clinical procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring. Record, report and interpret findings appropriately to develop study-specific database
  • Maintain and restock medical supplies as needed. Maintain cleanliness and sanitation of the unit
  • Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records
  • Prepare for and attend monitoring visits, audits, and inspections
  • Participate in quality and process improvement efforts to create and maintain a high-performing and efficient team
  • Assist with planning related to staffing and scheduling
  • Working knowledge of clinical drug trials
  • Experience working on an oncology study required
  • LPN preferred
  • Working knowledge of the principles of Good Clinical Practices (GCP)
  • In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
  • Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
  • Good skill in using MS Windows and Office applications such as Access, Outlook and Word
  • Bachelor’s degree or educational equivalent; or High school diploma and 3 years’ relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience
  • Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
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Clinical Research Coordinator Resume Examples & Samples

  • Clinical research operations. Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. May provide training to personnel
  • 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
  • Leadership and professionalism
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Clinical Research Coordinator Resume Examples & Samples

  • Communicates concerns regarding ethical violations to Manager/ Principal Investigator
  • Participates in meetings with research residents and research staff prior to implementation of protocol as necessary
  • Assembles source documents as necessary
  • Adheres to schedule and required procedures and follows research protocols
  • Maintains neat, Organizational, accurate and detailed source documentation, records and forms
  • Ensures proper collection, processing and shipment of specimen
  • Assists as needed in preparing for FDA and internal audits
  • Maintains data integrity where applicable
  • Ensures study supplies, office supplies and research equipment for research personnel/projects are maintained
  • Assists with grant applications, compiling literature reviews or the preparation of abstracts, entering information and/or maintaining databases for research department, ordering patient charts and placing reminder calls to patients as necessary
  • Promotes patient recruitment by preparing patient mailers, postcards or mass communications and participating in presentations as necessary
  • Screens and assigns patents to appropriate research protocols
  • Provides general support functions, including copying, filing correspondence transcriptions, obtaining required signatures as required
  • Works with department supervisor/manager to assist and train new hires in the research department/across all specialties
  • Reports and records adverse events/severe adverse events to Regulatory Coordinator, IRB Sponsor and PI and other agencies as required
  • Serves as primary contract for patient while enrolled in clinical trial
  • Reports all abnormal values to the PI in a timely manner
  • Attends conferences and meetings related to research as required
  • Experience working with Federal Regulations and IRB's preferred
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Clinical Research Coordinator Resume Examples & Samples

  • Oversee day-to-day operation of the project
  • Oversee IRB and other regulatory submissions
  • Oversee entry and update of study into ClinicalTrials.gov
  • Monitor expenditures across sites and maintain adherence to study budgets
  • Ensure compliance with research protocols, reviewing case report forms and auditing for accuracy with source documents
  • Compile study Manual of Procedures (MOP) and distributes to ADC site coordinators
  • Maintain communication and coordination with coordinators at three project sites outside of Atlanta and organizes bi-weekly project calls
  • Identify and coordinate study-related equipment and facility needs, including the approval of orders for supplies and equipment maintenance
  • Manage random assignment of subjects, in collaboration with project statistician
  • Perform ADRC site responsibilities
  • Experience managing human subject-based randomized trial
  • Experience with study data management, preferably using Excel, SAS and/or SPSS
  • Personnel management, preferably research personnel
  • Knowledge of IRB and other regulatory guidelines
  • Meticulous attention to the details of data acquisition, entry, and management
  • Ability to produce written and graphic materials for a variety of retention and dissemination activities
  • Experience with dementia/ caregivers and/or older adults a plus
  • Experience in multi-site studies a plus
51

Clinical Research Coordinator Resume Examples & Samples

  • Serves as a liaison with nurses, staff, physicians, pharmaceutical companies and federal agencies regarding patients who are on clinical trials, schedules in-service for appropriate staff, and provides patient education about treatment and possible side effects
  • Assists in the consent process and coordinates a variety of clinical research activities, ensuring that established protocols are implemented and followed
  • Participates in site initiation visits, monitoring visits and audits; maintains Human Subject Protection compliance; and adheres to patient confidentiality throughout the research process
  • Screens patients for clinical trials, ensuring patient eligibility; and maintains patient safety and protocol compliance
  • Collects, prepares, and organizes data, ensuring that data is collected into the appropriate format, electronic or paper submission of Case Report Forms
  • Assists physicians in completing flow-sheets in medical records and progress notes, and schedules audits with pharmaceutical sponsors and other agencies
  • Monitors, records and reports patient’s condition and reaction to drugs and treatments to the appropriate physician or nurse
  • Reports and documents serious adverse events and documents adverse events in patient CRF
  • Ensures that all requirements for pre-study laboratory/medical tests and eligibility are completed, and arranges pre- and post-procedure laboratory/medical tests
52

Clinical Research Coordinator Resume Examples & Samples

  • Screens patients for clinical trials, to include patient eligibility, and assists in the consent process
  • Collects, prepares, and organizes data into case report forms, databases, and other required formats
  • Assists physicians in completing flow-sheets in medical records and progress notes
  • Participates in site initiation visits, monitoring visits and audits, and schedules audits with pharmaceutical sponsors and other agencies
  • Reports and documents serious adverse events
  • Monitors, records and reports patient’s condition and reaction to drugs and treatments to the appropriate physician/nurse
  • Ensures that all pre-study laboratory/medical tests are completed and that eligibility requirements are completed
  • Arranges pre- and post-procedure laboratory/medical tests
  • Acts as a liaison with nurses, staff, physicians, pharmaceutical companies and federal agencies in regards to patients that are on clinical trials
  • Schedules in-service for appropriate staff, provides patient education about treatment and possible side effects
  • Performs all duties in accordance with all applicable laws and regulations and with Georgetown University Medical Center’s philosophy, policies, procedures and standards – to include Protection of Human Subjects and patient confidentiality
53

Clinical Research Coordinator Resume Examples & Samples

  • Knowledge of MedStar
  • Experience with drug and device studies
  • Strong computer skills, including word processing, spreadsheets, and database use
54

Clinical Research Coordinator Resume Examples & Samples

  • Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies
  • Disseminates information about the protocol to junior research staff
  • Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
  • Coordinates with data managers to monitor participant progression throughout study and conducts evaluation at end of study
  • Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study
  • Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed
  • Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations
  • Assures proper laboratory samples are collected and results reported to the proper entities
  • Assists the Principal Investigator in the development of study materials
55

Clinical Research Coordinator Resume Examples & Samples

  • Oversees compliance to multiple protocols, as defined by on-going and projected trials; manages quality control, completion and submission of study related documentation; prepares reports for research manager, Principal Investigators and sponsors, as requested
  • Develops study budgets in conjunction with research manager; monitors budget expenses for allied services; negotiates payment schedule with sponsor and fees for internal services
  • Disseminates information about protocols to diabetes clinic staff where applicable
  • Assesses protocol-driven eligibility criteria for multiple studies to screen and recruit study participants, coordinate with various providers and auxiliary services to schedule visits, creates source documents for data collection, conducts study visits, completes source documents and ensure accurate transcription of data into EDC within specific time parameters
  • Coordinates with CROs to monitor participant progression throughout study; investigates and resolves all study-related queries that may result from monitoring visits and/or internal audits
  • Develops and maintains a system to track patient visits and data entry for multiple studies; audits for completeness, and accuracy; may assist Research Manager in payment reconciliation for specific projects
  • Prepares for and coordinates site visits made by CROs, sponsors and/or federal agencies during the course of and at the close of the study
  • Works with investigational pharmacy to establish procedures for study drug delivery and/or administration
  • Assures proper laboratory samples are collected and results are reported to the proper entities
  • Assists the Principal Investigator in the development of study materials and protocols
  • Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Endocrinology Research Manager
  • Supports both the clinical and research services offered through the division’s Bone & Body Composition Suite by training with the Research Manager to operate the DXA, pQCT, ultrasound and air displacement plethysmographer; must demonstrate a high degree of precision and independence for operating DXA within 6 months of hire
  • Pass the Radiology Practical Technician exam in order to be eligible for licensing to operate bone densitometry equipment within 6 months of hire
  • Attends an internationally recognized bone densitometry course offered by the ISCD and sit for the exam in order to be eligible for national certification in the field of bone densitometry (Certified Bone Densitometry Technician—CBDT) within 1 year of hire
  • Demonstrates proficiency in scanning techniques utilized for various ages and health conditions in pediatric-specific population
  • Completes protocol-specific and/or study sponsor-specific DXA training under the guidance of the Research Manager
  • Prepares and disseminates bone densitometry reports following clinical review by division chief; attends weekly meetings with division chief and Research Manager to review patient reports, identifies quality issues, and troubleshoots as needed
56

Clinical Research Coordinator Resume Examples & Samples

  • Under the guidance of the clinical research manager, provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level
  • Prepares, submits, and maintains IRB, FDA, and other regulatory documents and research correspondence
  • Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution
  • Assures that adverse events are reported to the sponsor
  • Works with programmers to develop and test databases and other collection tools
  • Analyzes incoming data to identify trends, problems, or other issues
  • Prepares and interprets reports and queries for Investigators and Research Coordinators, which include, but not limited to monthly enrollment reports, reports of various data elements, query reports, etc
  • Ensures that captured data is accurate and corrects erroneous or conflicting data
  • Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions
  • Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety
  • Performs remote monitoring of site data in coordination with appropriate personnel
  • Attends required meetings and conferences as appropriate
  • Licensed professionals may be assigned medical reviews
  • Develops study budgets; monitors budget expenses and billing for allied services: negotiates payment schedule with sponsor and fees for internal services
  • Supervises, mentors and trains new or junior research staff
  • Assists the Investigators in the development of study protocols
57

Clinical Research Coordinator Resume Examples & Samples

  • Assist principal investigator with the day to day operation of her research lab and projects
  • Lead the communication coding lab and supervise research assistants; assess inter-rater reliability; assign hospice visit and phone recordings to be coded; conduct audits on coding progress
  • Liaison with National Palliative Care Research Cooperative to ensure cohesive study management and adherence to data collection protocols
  • Travel to research sites within the United States (locations yet to be determined). Train site staff on recruitment, enrollment, and study protocols
  • Basic knowledge of statistical analysis and ability to use various statistical analysis programs
  • Coordinate team meetings. Facilitate communication with internal and external stakeholders
  • Responsible for all study related reporting, including (but not limited to) IRB and NIH. Maintain compliance with all regulatory agencies
  • Preparation of scientific documents including peer-reviewed manuscripts
  • Financial management of NIH funded research study, including purchasing and human resources management
  • Complete all other duties as assigned
58

Clinical Research Coordinator Resume Examples & Samples

  • Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records
  • Disseminates information about the protocol auxiliary personnel
  • Works with the Data Coordinating Center to monitor participant progression throughout the study and conducts evaluation at pre-specified intervals and at end of study
  • Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
  • Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed
  • Assures proper laboratory samples are collected, labeled and shipped per study protocol and results are reported to the proper entities
  • Coordinates with physicians to provide information regarding available research projects and to maintain a strong referral basis
  • Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Cardiology Research Manager. This may include travel
  • Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator
59

Clinical Research Coordinator Resume Examples & Samples

  • Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services
  • Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study
  • Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues
  • Assists the Principal Investigator in the development of study protocols
60

Clinical Research Coordinator Resume Examples & Samples

  • In collaboration with the attending physician, recruits study subjects and ensures that all eligibility parameters are met. Ensures that informed consent is obtained prior to patient enrollment
  • Registers patients on clinical trials utilizing the appropriate registration process determined by the study group. Discusses the study with subject and obtains informed consent; schedules assessment/visits; assures study visits and tests are done at appropriate time intervals
  • Prepares packets for each newly diagnosed patient to include protocol consent, eligibility and
  • Daily review of next day’s clinic records to ensure that current and correct roadmap is available. Assists Care Coordinators and LIPs in obtaining current roadmap for all inpatients
  • Downloads information from clinical trial websites and maintains communication with the Children’s Oncology Group, the Therapeutic Advances in Childhood Leukemia (TACL), Pacific Pediatric Neurooncology Consortium (PNOC), Sunshine Pediatric Sarcoma consortium, and Medulloblastoma Neuroblastoma Consortium. Maintains protocols by ensuring that new protocols, amendments and closures are updated on notification from consortia
  • Responsible for all aspects of regulatory compliance for consortia within Primary Children’s Hospital
  • Tracks all regulatory activity generated from consortia or other study governing bodies. Prepares and submits protocols, protocol amendments and necessary progress reports for all protocols to IRB for approval in accordance with regulatory and/or IRB requirements
  • Assists physician investigator with communications to the various study chairs or group office as needed. Provides feedback to medical team on QA issues, protocol violations and documentation issues
  • Prepares all necessary documents for an Institutional Audit and/or site visit Peer Review Direct
  • Provides cross-coverage as needed to ensure that the work requirements are met. Attends to other duties as assigned by supervisor
61

Clinical Research Coordinator Resume Examples & Samples

  • Monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services
  • Recruits participants and monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining participant population availability, developing informed consents and screening materials, screening (and recruiting) participants, scheduling study visits, obtaining informed consent, answering participant inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
  • Provides oversight of all regulatory aspects of the research including maintenance of information on each protocol in ERICA
  • Creates the agenda scribes minutes and coordinates the Data Safety and Monitoring Board for all lab protocols
  • Manages the participant payment process
  • Handles Administrative functions for the lab
62

Clinical Research Coordinator Resume Examples & Samples

  • Work with identified hospital staff to determine the best times to complete observations within the unit
  • Accompany clinical staff to patient rooms only when the Michigan BioTrust and newborn screening is being discussed
  • Complete an observation form for each patient interaction
  • Record observations for 30 to 40 consents
  • Enter data into a spreadsheet and complete preliminary data analysis as guided by Erin Rothwell
63

Clinical Research Coordinator Resume Examples & Samples

  • Develops study budgets; monitors budget expenses for allied services; negotiates payment schedule with sponsor and fees for internal services
  • Disseminates information about the protocol to junior research staff and auxiliary personnel
  • Creates a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
  • Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Cardiology Research Manager
64

Clinical Research Coordinator Resume Examples & Samples

  • Compliance to study protocol; manages quality control, completion and submission of study related documentation; prepares reports for P.I., organizations and agencies
  • Adheres to enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities relate to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, obtaining blood/saliva/urine specimens, answering subject inquiries, overseeing study visits, and acting as a liaison between participants and study-related parties
  • Assists and coordinates with the team for site visits made by sponsors or federal agencies during course and at close of the study
  • Maintains patient databases and patients research study files
  • Travel between clinics is a must so own transportation is needed for those days (rotating schedule). Occasional patient recruitment my occur evenings and week-ends, must be available to assist
65

Clinical Research Coordinator Resume Examples & Samples

  • Provide support to clinical research project manager and PI by reviewing study budgets, industry proposals, and federal grants
  • Work with project manager to assist with study start up: shepherding study agreements through the pulmonary and medicine Clinical Research Units, drafting Case Report Forms, Duke IRB and other regulatory documents
  • Independently responsible for subject enrollment, data collection, data entry into paper or electronic CRFs and the Palmer lab database, and all other operational study components
  • Prepare and organize all IRB documentation. -Independently procure, process, and inventory biological samples
  • Work with database manager to extract data from the database for data analyses
  • Assist with data analyses and construct tables and figures for presentations or manuscripts
66

Clinical Research Coordinator Resume Examples & Samples

  • Recruit study participants by establishing referral methods and working with our clinical partners, as well as implementing a successful plan in line with approved protocol to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
  • Work closely with the Center Administrator and Clinical Research Coordinator, Sr. to support the activities of all team members
  • Ensure each participant meets eligibility requirements prior to scheduling of screening visits
  • Explain project to participant and enroll them into the study
  • Schedule and/or coordinate the scheduling of required laboratory tests and/or exams. Maintain contact and develop rapport with participants throughout the project; searches for participants that have changed addresses during the project
  • Mail questionnaires to participants to complete or ask them questions by telephone or in person; compile results of questionnaires
  • Complete case report forms for each study participant and maintain and organize participant binders, ensuring that protocol is being followed and consents are up-to-date
  • Enter data from case report forms into electronic database and prepare quarterly reports utilizing the database
  • Work with Clinical Research Coordinator, Sr. to maintain inventory of data collection supplies and requisition supplies and equipment as needed
  • Proactively track initiative to ensure recruitment stays on track with project timelines
  • Previous human subjects training (e.g. CITI certification) and two years experience as a research coordinator with direct recruitment and enrollment responsibilities
  • Familiarity with UA and external (FDA, NIH) clinical research regulatory bodies, and experience with use of electronic data capture systems (such as REDCaps)
  • The ideal candidate will be fluent in English and Spanish with excellent organizational and interpersonal skills
67

Clinical Research Coordinator Resume Examples & Samples

  • Minimum of 5 years clinical research experience
  • Bachelor’s degree in neuroscience or healthcare related field
  • Certified Clinical Research Coordinator (CRC)
68

Clinical Research Coordinator Resume Examples & Samples

  • Regulatory affairs
  • Patient recruitment and enrollment
  • Long distance travel logistics
  • Study visit interviews
  • Data abstraction
  • Surgical procedure arrangements
69

Clinical Research Coordinator Resume Examples & Samples

  • "Provides superior customer service to internal and external clients, customers, and patients as referenced in the Service Excellence Standards."
  • Performs duties as needed to coordinate clinical research studies/clinical trials to include but not limited to the following
  • Ability to work closely and productively with other members of an interdisciplinary team
  • Ability to analyze operational issues and solve them creatively
  • Accuracy and attention to detail
70

Clinical Research Coordinator Resume Examples & Samples

  • On a periodic basis and with notice, adjust regular working schedule to provide weekend or evening enrollment coverage as needed
  • Maintain a detailed tracking data entry for participants. Track progress at regular intervals and report out to PI and study team
  • Bachelor’s degree in a field appropriate to the area of assignment AND two years related research experience; OR, Six years research experience appropriate to the area of assignment; OR, Any equivalent combination of experience, training and/or education approved by Human Resources
71

Clinical Research Coordinator Resume Examples & Samples

  • Collaborates closely with Ironwood Clinical Study Managers, study teams and CRO partners
  • Supports implementation and management of clinical research studies through file management and clinical project document control
  • Assists the Ironwood clinical project teams in project related activities, such as creating study binders, shipping study documents, and drafting newsletters
  • Reviews and tracks clinical trial regulatory documents
  • Re Assists in the planning and preparation for investigator meetings
  • Maintains study tracking tools and study calendars
  • Works closely with Ironwood Records Management, Ironwood Regulatory, and CROs to ensure adequate clinical trial documentation
  • Completion of telephone logs, notes to file, and status reports
  • Participates in study team meetings and drafts meeting minutes and agendas
72

Clinical Research Coordinator Resume Examples & Samples

  • Organizes research information for clinical projects
  • Selects and observes subjects and assists with data analysis and reporting
  • Oversees experiment scheduling and collection of data
  • Familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals
  • Works under general supervision
  • A certain degree of creativity and latitude is required
  • 3 years of work experience in clinical research setting as research coordinator
73

Clinical Research Coordinator Resume Examples & Samples

  • Develop and maintain training manuals for study sites. Train study sites in correct collection, processing and shipping of bio-specimen and data. Update study protocols and consents as necessary to meet changing needs of the study
  • Provide consent template language to study sites. Prepare study progress reports and present information on a weekly basis to the study sponsor and PIs of study sites
  • Work directly with study participants to determine subject eligibility and obtain consent. Educate participant and families on disease and study protocol
  • Maintain current scientific knowledge of bio-specimen collection and uses. Educate participants and families on study protocol. Monitor sites for study compliance, regulatory compliance and quality control. Position involves ability to make decision that directly impact the study and subsequently the study funding
74

Clinical Research Coordinator Resume Examples & Samples

  • Good social skills, including the ability to work easily with research participants and research team members
  • Well organized, attention to detail, excellent verbal and written communication skills in English
  • Experience managing a small team
  • Preference given to applicants with previous clinical research experience with older adults or those with motor and/or cognitive disabilities
  • Strong analytical skills and experience with computer spreadsheets and database software
  • Ability to work empathetically and professionally with older adults who may have neurological impairment (e.g. Parkinson’s disease) or cognitive impairment
75

Clinical Research Coordinator Resume Examples & Samples

  • Direct contact with patients to gather medical history data and provide therapeutic guidance under the supervision of the clinical leads
  • Arranging appropriate clinical and laboratory follow up
  • Monitoring and Reporting of adverse events
  • Communicating Treatment Plans to the patient’s primary care providers
  • Data gathering for quality control
  • Leading interface with Project Team to provide real time updates regarding recruitment, patient experience, and other metrics
  • Provides excellent customer service. Ensures customer/patient satisfaction and compliance with protocols
  • Works in daily collaboration with Physician Lead and Manager to resolve issues related to the patient recruitment and experience
  • Acts as a patient advocate for any questions or issues regarding service and recruitment delivery
  • Develops tools and resources for all protocol staff
  • Responsible for reviewing weekly ACD reports and quality audit reports. Responsible for reviewing quarterly audits with staff and providing one on one retraining when applicable. Oversees operational changes associated with call center operations and Watkins Center practice standards
  • Provides orientation, training and coaching of all new team members. Mentors all team members and assists in identifying re-training subject matter
  • Actively participate in regular protocol meetings
  • Assists physician lead and manager with special projects as assigned
  • Performs all other duties and tasks as requested to ensure the efficient overall performance meeting targets
  • Potentially schedules study visits for study subjects
  • Enters data into databases created in Microsoft Access and other systems
  • Schedules study visits by interacting (via phone, email, or fax) with the following persons and entities: study subjects, Study staff, including research coordinators, study physicians, and other support staff
  • Assists with IRB preparation of amendments
  • May lead work study students engaged in data entry or other tasks
  • Prepares study summary reports regarding recruitment status and study’s progress. Takes an active role in subject recruitment methods
  • Stays current and up to date with position’s trainings and certifications
  • Performs other administrative functions as required, e.g., reconciling invoices, organizing investigator and staff meetings, assisting with web searches
  • Maintains confidentiality with regard to patient information and other sensitive information
  • Greets and provides assistance to visitors, subjects and employees in a professional and courteous manner
  • Develops and implements measures to improve efficiency in office operations
  • Performs other task as requested
  • 2-5 Years Healthcare experience
  • Verbal skills: Ability to interpret information as appropriate, answer more complex questions in the most professional manner and communicate in a professional, courteous, clear and concise manner
  • Organization Skills: Ability to manage work processes in a neat and orderly way and to sort and alphabetize. Ability to manage multiple tasks effectively, follow established protocols and Unit’s SOPs, and work within systems
  • Intermediate understanding and use of medical terminology
76

Clinical Research Coordinator Resume Examples & Samples

  • Academic and/or work experience related to medicine, science and statistics
  • Experience with specialized word processing and spreadsheets
  • Keen interest in medicine/life sciences
77

Clinical Research Coordinator Resume Examples & Samples

  • Data management and informatics. Use and train others in ElectronicData Capture (EDC)systems, technologies, and software necessary for study operations.Enter data accurately. Scoretests and measures according to protocol and appropriate to role.Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions. May independently design ECRFs andEDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.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 ofdata. 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 securityand 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. May be responsible for determining solutions to vulnerabilities related to security of data and data provenance.Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are inplace (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions(IDEs), etc.)
  • Scientific concepts and research design. Understand and train other sin the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify short comings 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. Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead acommittee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members.Participate in or lead scientific presentations and publications
78

Clinical Research Coordinator Resume Examples & Samples

  • Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
  • Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
  • Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
  • Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at Compass Research
  • Complete all monitor and sponsor queries in a timely manner
  • Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient’s participation in study
  • Learn and support the mission and goals of Compass Research’s program
  • Ability to communicate clearly/effectively (written and oral)
  • Some prior experience in a clinical environment required – preferably in a clinical research setting in the position of Research Assistant or CRC
  • LPN, RN, or other medical license or certification preferred
79

Clinical Research Coordinator Resume Examples & Samples

  • Associate's Degree in Nursing and/or Bachelor's degree in a health related field
  • Active New York State Registered Nurse license
  • 1+ year of clinical research experience
  • Certification in the Protection of Human Research Subjects
  • Knowledge of computer programs such as Microsoft Word and Excel
  • Proficiency in the use of computer programs for documentation development, documentation, and the creation and use of spreadsheets
  • Excellent organizational, interpersonal, verbal and written communication skills
80

Clinical Research Coordinator Resume Examples & Samples

  • Six (6) years equivalent combination of experience in research, training and/or education approved by Human Resources; OR
  • Bachelor’s degree in a field appropriate to the area of assignment and two years related research experience
  • Knowledge of the principles, practices and techniques of research clinical skills
  • Experience with research protocols, development, regulations
  • Motivated to provide high quality, compliant research
81

Clinical Research Coordinator Resume Examples & Samples

  • Adheres to and supports the mission, purpose, philosophy, objectives, policies, and procedures of Tenet Physician Resources
  • Adheres to the Tenet HIPAA Compliance Plan and the Privacy Standards Confidentiality Agreement
  • Demonstrates support for the Tenet Corporate Compliance Program by being knowledgeable of compliance responsibilities as expressed in the Code of Conduct; adhering to federal and state laws, rules, regulations, and corporate policies and procedures policies that affect his/her specific job functions/responsibilities; and reporting compliance issues/concerns in a timely and appropriate manner
  • Be knowledgeable of protocols and adhere to Tenet Clinical and Administrative Standards of Practice
  • Develop recruitment plans, assemble and organize materials
  • Meet with Sponsors, Groups, Hospital officials, meet with PIs and ancillary staff prior to study initiation
  • Assist in writing informed consent forms
  • Screen and recruit study subjects, obtain and document informed consent
  • Document clinical research processes, medical procedures in source documents
  • Complete case report forms within 10 working days of study visits
  • Conduct study visit assessments, data collection, process central lab samples, obtain results
  • Do simple clinical tests
  • Administer study medication, including parenteral administration
  • Educate patients and family on study processes, study drug, informed consent process, study progress, visit appointments, contact numbers, issues under study and drug interactions
  • Maintain ongoing oversight of study project activities, status and timeliness
  • Reach recruitment goals or make recommendations on re-setting recruitment goals
  • Interface with research manager, PIs and research committee
  • Locate missing patients and document lost-to-follow-up
  • Attend research meetings, staff meetings, PI meetings, monitor meetings, conference calls
  • Carry beeper and be responsive to digital pages, rotate onto call schedule, as appropriate
  • Attend monitor and FDA audits
  • Reconcile study queries from sponsors
  • Interface with IRBs and Regulatory Affairs Coordinator
  • Perform drug accountability processes
  • Maintain study-associated supplies and inventory
  • Make prospective study appointments and notify/remind patients of their appointments
  • Delegate responsibilities to support staff, as appropriate
  • Participate in assessing new study feasibility
  • Adhere to compliance policies and procedures. Report any incident that appears
  • Knowledge of medical office procedures and process
  • Knowledge of clinical equipment, supplies, and instruments
  • Understanding of documentation required for physician office visits
  • Knowledge of the purposes, organization, and policies of the local community's health systems sufficient to interact with other health care
  • Skill in computer hardware and software use
  • Skill in verbal and written communication
  • Skill in exercising a high degree of initiative, judgment, discretion, and decision-making to achieve organizational objectives
  • Skill in analyzing situations accurately and taking effective action
  • Skill in establishing and maintaining effective working relationships with employees, policy-making bodies, third-party payers, patients, and the
  • Skill in exercising judgment and discretion in developing, applying, interpreting, and coordinating departmental policies and procedures
  • Ability to obtain vital signs and record them correctly
  • Ability to administer IV and Injections appropriately
  • Ability to mix medications
  • Ability to use medical equipment, supplies and instruments
  • Ability to understand and carry out written, oral and/or graphic instructions
  • Ability to multi-task, manage details and organize efficiently and effectively
  • Ability to read, interprets, and apply policies and procedures
  • Ability to set priorities among multiple requests
  • Ability to interact with patients, medical and administrative staff, and the public effectively
  • Ability to use EMR, other relevant computer hardware and software, telephone, copier, fax machine and other standard medical office equipment
82

Clinical Research Coordinator Resume Examples & Samples

  • Knowledge of psychiatric and medical nursing procedures is preferred
  • Knowledge of regulatory guidelines regarding research (e.g. “Common Rule”, “GCP” etc.)
  • Knowledgeable on medical coding and billing procedures in a physician practice setting
  • Ability to evaluate the effectiveness of existing methods and procedures
  • Ability to communicate effectively with patients, clinical and administrative staff and the public
  • Ability to interpret, adapt and apply guidelines and policies and procedures
  • Skill in dealing with interpersonal issues and customer relations
  • Ability to handle multiple priorities at once with minimal supervision
  • Ability to plan, organize, delegate and supervise
  • Minimum of two to three solid years of medical office experience in a supervisor or lead role
  • Proven performance in solving operational issues within a healthcare setting
  • Proven performance leading a successful team in a fast paced healthcare setting
83

Clinical Research Coordinator Resume Examples & Samples

  • Oversees compliance to study protocols: manages quality control, completion and submission of study-related documentation; prepares reports for organizations and agencies
  • Collaborates with study sponsors and PIs to establish study objectives, procedures, and deadlines for each project. Oversees day-to-day research activities, ensuring that progress is made to achieve study objectives and deadlines while preserving the integrity of scientific research
  • Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and carries out responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, obtaining informed consent, answering subject inquiries, overseeing study visits, and acting as a liaison between participants and all study-related parties
  • Provides study-specific education and training for faculty, fellows, Primary Children’s Hospital clinical and ancillary staff, and students
  • Develops and maintains study databases for all research projects, including data collection, query management, establishing and monitoring timeline development, and data quality
  • Recognizes, tracks, and reports adverse events and protocol deviations
  • Prepares for and coordinates site visits made by sponsors or federal agencies
  • Prepares, submits and maintains IRB, FDA, NIH and all other regulatory processes to ensure compliance with good clinical research standards and practices
  • Collaborates with division manager to monitor study expenditures, order supplies, assist with budget / funding updates and analysis of appropriate expenditure of funds
  • Coordinates and prepares reports for internal and external customers, including division chief and manager, project investigators, university offices, study sponsors and collaborating institutions
  • Assists in assessing, planning, designing, budgeting, and initiating future studies, and assists with grant application activities
  • Performs other necessary research support functions as assigned by division chief, manager, or project investigators
  • Establishes and maintains collaborative community relationships, particularly with Intermountain Healthcare / Primary Children’s Hospital, and the PECARN research network. Travels to required meetings for training and collaboration
  • Provides continual didactic education and on-the-job training and feedback to Academic Associate students, providing continual feedback and study updates in order to enhance their learning experience and guarantee the quality of their work
84

Clinical Research Coordinator Resume Examples & Samples

  • Assists in the development of study materials and protocols; oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies
  • Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study
  • Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed. Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
  • Performs medical reviews analyzing or evaluating clinical data and serves as a team resource for non-clinician staff
  • Administers investigational drugs and monitors side effects
  • Performs investigational surgical or radiological procedures and detailed clinical assessments
  • Provides nursing care as necessitated by the response of the participant to the study intervention
85

Clinical Research Coordinator Resume Examples & Samples

  • Determine patient eligibility and obtain informed consent for clinical trial participation
  • Conduct clinical visits according to approved research protocols in an emergency department setting
  • Handling and processing of biomedical specimens
  • Review medical records and document protected health information for study records
  • Bachelor’s degree in health-related field
  • One year of clinical research experience
86

Clinical Research Coordinator Resume Examples & Samples

  • Ensure each collection site is properly set up and maintained in accordance with standards set by the FDA, Health Resources and Services Administration (HRSA), the Federation for the Accreditation of Cellular Therapies (FACT), and the National Marrow Donor Program (NMDP). This includes equipment, safety procedures, and cleanliness
  • Prepare sites for annual audits and inspections, communicate with QSU, respond to findings and complete reports
  • Ensure collection SOPs meet requirements according to FDA and other accrediting agencies
  • Develop, validate, and implement policies and procedures and work in collaboration with the Collection Site Coordinator to develop, train and implement new site processes and CCBB expansion
  • Review and ensure collection paperwork and data entries are accurate
  • Initiate and complete deviations related to the collection and transportation process
  • Collaborate with QSU, as needed, to investigate errors and develop and implement CAPAs
  • Followup with training, as necessary
  • Oversee Medical History approvals, CBU exclusions and CBU status in collaboration with the Medical Director and CCBB processing lab
  • Coordinate research studies at collection sites by liaising with the researchers, the laboratory and the collection site staff
  • Create and maintain training documentation and records, in collaboration with the Training Coordinator, for sites both with and without Master Control access and for NMDPMD/CNM training
  • Supervise kit and kit collection sites programs
  • Ensure goals are met
  • Manage CCBB personnel working on these programs
  • Supervise couriers
  • Allocate and maintain EMMES study IDs for CCBB staff and providers
  • Coordinate approval, collection and processing of directed donations
  • Oversee that supplies are stocked, ordered and available for collections, at all sites
  • Coordinate the efficient transportation of cord blood units to North Pavilion
  • Maintain records management for confidential packets and ISBT barcodes
  • Completion of a Bachelor's degree; or Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
  • Experience in cord blood banking is highly desirable, but not required
87

Clinical Research Coordinator Resume Examples & Samples

  • Oversee the general operation of the CCBB at the UNC site
  • Oversee other Duke personnel working at this site
  • Plan and manage monthly site schedule
  • Perform general site supervision activities
  • Be an ambassador for the CCBB program
  • Establish good working relationships with UNC personnel involved in the cord blood collection process
  • Develop and enhance all aspects of CCBB UNC with the goal of promoting public cord blood banking
  • Represent CCBB in interactions with other UNC departments
  • Make presentations to hospital staff and community groups to increase awareness of CCBB at UNC
  • Educate potential donors about public cord blood banking by telephone, in OB offices, and in community groups
  • Educate the potential mother/donor about public cord blood banking so that she can make an informed choice regarding the volunteer donation of her infant's cord blood
  • Assist UNC staff obtain informed consent from mother/donor by providing information and discussion of the consent form, culminating with a written and signed document
  • Obtain a detailed medical history from mother/donors following delivery and informed consent
  • Record information on the Medical History Form and accurately enter into CCBB database
  • Obtain delivery and neonatal information by reviewing the medical records of the mother and infant donor, and accurately record information on the appropriate form, performing follow up with OB clinical staff when needed
  • Enter collection and donor information in the CCBB data systems
  • Perform final reviews on all paperwork leaving the collection site, ensuring accuracy and completeness of all recorded information before it is delivered to the Collections Site Coordinator
  • Ensure delivery of the informed consent, medical history, and delivery information forms to the CCBB laboratory and administrative offices for verification and inclusion into the cord blood unit files
  • Ensure that maternal blood samples for infectious disease testing are collected by the collection site phlebotomist according to standard operating procedures. If samples are missed or are otherwise unusable, facilitate the collection of new samples
  • Educate and advise UNC personnel on the most effective collection techniques
  • Ensure supplies are readily available at the site for UNC personnel to collect the umbilical cord according to CCBB collection procedures
  • Prepare the collected umbilical cord blood for delivery to the cord blood processing laboratory for processing and storage
  • Ensure and maintain complete confidentiality with regard to identity of the maternal/infant donor pair, as well as results of any tests and procedures, in accordance with CCBB standard operating procedures
  • Assist with other obstetrics (OB) research projects as assigned
  • Participate in the Quality Assurance Program for the development, implementation, and evaluation of cord blood banking, which may include writing and editing of standard operating procedures as directed by the Quality Manager for the CCBB program
  • Completion of a Bachelor's degree, or
  • Completion of an Associates degree plus a minimum of two years relevant experience (e.g.,research, clinical, interaction with study population, program coordination)
88

Clinical Research Coordinator Resume Examples & Samples

  • Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance
  • Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
  • Collect, process, and ship blood, urine and tissue specimens as outlined in oncology clinical trial protocols
  • Process samples per study instructions. This may include using centrifuge, liquid nitrogen, making slides
  • Packaging and shipping specimens with IATA regulations
  • Must be able to work independently and have strong communication and human relations skills
89

Clinical Research Coordinator Resume Examples & Samples

  • Responsible for coordinating the research activities of assigned IRB-approved study protocols Reports and is responsible to the Principal Investigator (PI) and supports the CID department head in accordance with federal and local regulatory guidelines
  • Coordinate research activities and direct patient care of assigned IRB approved protocols such as physical assessments, vital signs, assessing specific signs and symptoms, and drawing blood (if applicable)
  • Administers investigational drugs as specified in the protocols
  • Use managerial, communication (written and verbal) and leadership skills in all PI and human subject interaction
  • Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
  • Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design
  • Process and prepare specimens for lab analysis and shipping as applicable
  • Observe universal precautions and OSHA standards when processing or handling specimens
  • Report adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations
  • Return telephone calls from research participants in an efficient and timely manner and document interaction