Clinical Research Associate Resume Samples

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SD
S Donnelly
Sven
Donnelly
64789 Meaghan Avenue
Phoenix
AZ
+1 (555) 512 2584
64789 Meaghan Avenue
Phoenix
AZ
Phone
p +1 (555) 512 2584
Experience Experience
New York, NY
Clinical Research Associate
New York, NY
Farrell-Schmeler
New York, NY
Clinical Research Associate
  • Make recommendations for improvements to your Manager
  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA
  • Independently performs CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems
  • Reviews clinical data/information and oversees data correction. Assists study managers in providing interim and final reports and presentations
  • Works under supervision to manage work flow to accomplish assigned objectives
  • May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes
  • Working with management to develop project-specific CRA training
Dallas, TX
Lead Clinical Research Associate
Dallas, TX
Cassin, Bosco and Pouros
Dallas, TX
Lead Clinical Research Associate
  • Assists the Project Manager/Clinical Trial Manager with UAT testing and eCRF guideline review
  • Monitors site performance and compliance and provide management with necessary reports, updates and recommendations
  • Develops Clinical Monitoring Plans with review from the CRA Manager
  • Assists in evaluation of vendor performance during conduct of the study
  • Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager
  • Tracks utilization of visits against the budget in conjunction with the study Project Manager/Clinical Trial Manager
  • Develops Monitoring tools, Source Document Templates, and trip report annotations with review from the CRA Manager
present
Houston, TX
Senior Clinical Research Associate
Houston, TX
Hegmann, Padberg and Gerhold
present
Houston, TX
Senior Clinical Research Associate
present
  • Arranging on-site visits and logistics
  • Providing microbiology lab support to clinical programs
  • Supporting Product Development Lab with In House Clinical Study (ICS) screening and verification testing during development
  • Conducting study site feasibility assessments and qualification visits
  • Managing and coordinating cross-functional project teams
  • Serving as the primary project contact with the Sponsor (Customer)
  • Monitoring team performance against contract, customer expectations, and project baselines
Education Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
California State University, Northridge
Bachelor’s Degree in Science
Skills Skills
  • Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials in general
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
  • Project management experience including the ability to prioritize, plan & evaluate deliverables; is well organized and structured, strong attention to detail
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
  • Comfortable with technology and ability to learn new systems quickly
  • Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
  • Attention to detail and the ability to prioritize. Strong organizational, planning and follow-through skills
  • Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
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15 Clinical Research Associate resume templates

1

Lead Clinical Research Associate Resume Examples & Samples

  • Prior Oncology experience
  • Strong experience with EDC systems experience
  • Able to demonstrate the critical elements of GCPs and federal regulations as it relates to clinical monitoring, IRB and Investigator responsibilities
  • CCRA certification
2

Senior Clinical Research Associate Resume Examples & Samples

  • At least 6 years of experience in clinical research
  • Bachelor's Degree or higher, scientific discipline is preferred
  • Thorough understanding of drug development
3

Senior Clinical Research Associate Resume Examples & Samples

  • 4-6 years industry experience, including a minimum 4 years clinical research experience
  • Competent in the skills for the CRA II
  • Experience in line management and/or mentoring of CR Assistants and CRAs
  • Contributes in process improvement teams
  • Understanding of the clinical development plan and how the individual
  • Bachelor’s degree in biological science preferred
  • Combination of educational and work experience providing competencies to perform the required accountabilities specific to position
4

Senior Clinical Research Associate Resume Examples & Samples

  • 3-5 years of CRA experience
  • IVD experience is preferred
  • Operational expertise
  • Experienced in presenting study-related material
  • Experienced in writing professional emails to both internal and external customers
  • Oncology clinical trial experience highly preferred
  • Laboratory/Med Tech background highly desirable
  • Bachelor's or Masters in Biology, Chemistry, Molecular Biology or related discipline
  • Global study experience/experience managing sites located in Europe/Asia
  • Ability to work in a team situation
  • Budget and contract development
  • Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems
  • Must meet timelines and manage sites
  • MSWord, Excel and PowerPoint skills are required
  • Experience developing professional presentations and presenting to investigational sites and management
5

Clinical Research Associate Resume Examples & Samples

  • Bachelor’s degree in Biology or related discipline
  • 1+ years of experience within the biotechnology or pharmaceutical industry; drug development experience preferred
  • Working knowledge of good clinical practices (GCP)
  • Proficiency in Microsoft Office Suite
6

Senior Clinical Research Associate Resume Examples & Samples

  • Bachelor’s degree in a science-related discipline and/or Registered Nurse licensure required
  • 2+ years as a clinical research monitor; dermatology experience preferred
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated understanding of Good Clinical Practices and Standard Operating Procedures
  • Flexibility to travel domestically up to 60-80% as required
7

Senior Clinical Research Associate Resume Examples & Samples

  • Bachelor’s degree in a scientific discipline and/or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology)
  • 4+ years of clinical research monitoring experience; 3+ years of oncology experience preferred
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
  • Understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
8

Clinical Research Associate Resume Examples & Samples

  • 3+ years of experience as Clinical Research Associate; experience in early development trials preferred
  • Bachelor’s degree in Biology, Pharmacy, or similar health-related discipline
  • Strong regulatory knowledge (including GCP)
  • Flexibility to travel up to 65% domestically
9

Lead Clinical Research Associate Resume Examples & Samples

  • 4+ years of relevant industry experience in a CRO, pharmaceutical company or biotechnology company
  • Comprehensive understanding of all aspects of clinical trial documentation, including Clinical Study Report compilation
  • Strong familiarity with industry standards as applied to ICH guidelines, GCP, and the CFR
  • Working knowledge of clinical monitoring responsibilities and procedures
10

Senior Clinical Research Associate Resume Examples & Samples

  • 3+ years of Clinical Research (CRA) and/or Clinical Research Management experience with demonstrated experience in multi-national and/or multi-site clinical studies; 3+ years of experience working as a Clinical Trial Coordinator as part of a research team in a Hospital
  • Experience with ultrasound contrast agents
  • Working knowledge of GCPs, CFR, and ICH guidelines
  • Experience in diagnostic imaging field
11

Senior Clinical Research Associate Resume Examples & Samples

  • 5+ years of experience in Pharmaceutical Clinical Research
  • Associate's Degree in a Scientific / Healthcare field
  • Extensive knowledge of ICH/GCP guidelines and regulatory requirements
  • Respiratory experience
12

Clinical Research Associate Resume Examples & Samples

  • Partners with CAPMs and project team members to perform initial contact with potential investigators and participates in the assessment and selection of qualified investigators for inclusion in research
  • Performs Qualification, Initiation, Monitoring,
  • Works with research site personnel to ensure all research activities are run compliantly and according to protocol
  • Perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and GCP/applicable regulatory guidelines. Help to define quality standards within the project team
  • Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports
  • Reviews ethics committee reports
  • Ensures compliant recording and reporting of
  • Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. with a minimum of 2 years experience with clinical research, OR minimum of 6 years progressive experience with clinical research
  • Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)
  • Good collaborative oral and written communication skills, with ability to relay pertinent information to site personnel and study teams
  • Strong team skills with ability to work effectively with GEHC and research site personnel
  • Ability to travel up to 70% of time for job related responsibilities
  • Computer literate; Proficient Microsoft Office skills including Word, Excel, and Outlook. Ability to adapt to multiple technology platforms/systems
  • Experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail
  • Clinical trial professional certification, e.g. CCRP, CCRA or CCRN
  • Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc
  • Knowledge of Quality Management Systems
  • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
  • Demonstrated ability to work well
  • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
13

Senior Clinical Research Associate Resume Examples & Samples

  • Manage and have accountability for clinical operations activities for all clinical trials for Client and potentially full project management responsibility for 1 or more smaller clinical trials including but not limited to
  • Protocol authoring and CRF design/development
  • Site selection and start up activities
  • Management of clinical monitoring activities
  • Clinical document authoring including informed consent forms, monitoring tools, CRF completion instructions, investigator brochures, etc
  • Additional responsibilities include
  • Act as the primary contact person for the clinical sites and vendors
  • Manage study CRAs and monitoring activities (including co-monitoring)
  • Lead feasibility activities as needed
  • Assist with outsourcing services to vendors including preparation of request for proposals, analytical review and feedback on vendor proposals and statements of work and direct input into the recruitment and selection of vendors
  • Manage clinical site contracts and payments
  • Manage central IRB or Ethics Committee approvals at sites for trials
  • Liaise with clinical data management lead and/or the data management vendor, if applicable, to ensure quality data is produced for each clinical trial in accordance with the protocol, statistical analysis plan and ICH/GCP and other regulatory requirements
  • Responsible for monitoring and tracking clinical drug supplies at the study sites
  • Responsible for evaluating clinical site and vendor performance
  • Assist with regulatory IND/NDA submissions as needed Participate in clinical audits, lead the effort to track and collect missing or outdated documents or follow up on outcome of clinical audits
  • Ensure understanding of appropriate Client SOPs, ICH-GCP guidelines
  • Ensure studies and clinical project deliverables are performed with quality standards and in accordance with ICH/GCP and other regulatory requirements
  • Additional duties as assigned by Director, Clinical Projects or VP R&
  • Strong understanding of the clinical trials process and regulatory requirements
  • Proven track record of successfully managing clinical trial activities in a quality manner and within the projected timeline and budget
  • Able to lead and work within teams and networks with internal and external team members promoting collaboration, effective work procedures and effective communication among the team
  • Demonstrate conceptual, analytical and strategic thinking
  • Demonstrate effective problem solving
  • Able to understand the impact of technology on studies and to use and develop computer skills
  • Current GCP training
  • Previous site monitoring experience
  • CRA or project management assistance in a pharm/biotech company
  • Expert in MS Word, Excel, and PowerPoint required, MS Project experience a plus
  • Possess excellent English language written and verbal communication skills
  • Strong organizing and planning skills to work independently with efficiency and accuracy
  • Ability to travel up to 15%
14

Clinical Research Associate Resume Examples & Samples

  • Clinical Research responsibility for marketed products, product modifications and/or assigned New Product Introduction (NPI)
  • Coordination of safety plans with Corporate Toxicology and scheduling of biocompatibility testing
  • Supporting Product Development Lab with In House Clinical Study (ICS) screening and verification testing during development
  • Conduct study site feasibility assessments and qualification visits
  • Bachelor's degree or higher in a Science or Engineering discipline from an accredited institution
  • Minimum of two (2) years clinical research experience
  • Bachelor’s degree or higher in Science, Nursing, Clinical Research or related discipline from an accredited institution
  • Certifications that include
  • Association of Clinical Research Professionals (ACRP, Certified Clinical Research Associate (CCRA) and/or
  • Society of Clinical Research Professionals (SOCRA), Clinical Research Professional (CRP)
  • Experience in one or more of the following areas: vascular access research, wound care research and/or skin research
  • Experience and knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Food and Drug Administration (FDA) guidelines
  • Knowledge and experience with regulatory function
  • Experience in new product development programs
15

Clinical Research Associate Resume Examples & Samples

  • Completion of an allied health degree in clinical research. Associates degree in Clinical Trials Research related curriculum plus a minimum of eight years’ research experience (oncology preferred) or
  • Completion of a bachelor's degree plus a minimum of three years closely related research experience (oncology preferred) or
  • Completion of a master's degree in a health related field with four years directly related clinical trials research experience
  • Certification/license to practice as a Registered Nurse in North Carolina preferred. If not licensed, must be eligible for licensure/certification, other certifications as appropriate
  • Monitoring experience
  • Knowledge of the ICH guidelines, Good Clinical Practice (GCP ) DHHS, and FDA regulations
  • Experience in clinical research and regulatory processes and functions required
  • Experience in oncology preferred
  • Highly organized with attention to detail and knowledge of scientific, medical, and regulatory terms
  • Computer literacy, particularly in report design
  • A person with research experience at Duke Medicine or another academic-based health care delivery system with knowledge of clinical practice and research standards in a network setting
  • Clinical experience including but not limited to Nursing/patient care experience
  • Clinical Research Background*
  • Clinical Trials Monitoring Background*
  • Patient care experience*
  • = strongly preferred
16

Clinical Research Associate Resume Examples & Samples

  • Oversee and review routine and moderately complex site activities, withminimal tono guidance,through monitoring activities, including on-site visits and/or in-houseassessments, includingtelephone contact, and other technologies according to thetrial-specific monitoring plan to assessprotocol, regulatory, and SOP compliance with some guidance from anexperiencedCRA or aclinicaltrial lead
  • Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum offour yearshealthcare experience; or
  • Completion of a master's degree in Public Health,., HealthAdministration or a related area with. one year directly relatedclinical trials research experience; or
  • Completion of a bachelor's degree plus a Minimum of two yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of three yearsclosely related research experience.**State of North Carolina license may be required.**
17

Clinical Research Associate Resume Examples & Samples

  • Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or
  • Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or
  • Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or
  • Completion of a bachelor's degree plus a minimum of three years closely related research experience
18

Clinical Research Associate Resume Examples & Samples

  • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
  • Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
  • Masters degree in a science related field with a minimum of 3 years experience with clinical trials management within the healthcare industry or Bachelors degree with 4 years experience in monitoring clinical trials
  • Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results
  • Proven communication skills, both written and verbal, at all levels of an organization
  • Must be willing to travel as required
  • Must be legally authorized to work in the United States full-time
  • Must be willing to work in our [city, state] facility full-time
  • Must submit application for employment through gecareers.com (or COS if internal) to be considered
  • Must be willing to take a drug test as part of the selection process
  • Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
  • Well organized and structured, attention to detail
  • Ability to work independently and systematically
  • Diplomatic, cooperative teamworker
19

Senior Clinical Research Associate Resume Examples & Samples

  • Designs, plans, conducts, and monitors clinical studies
  • Prepares clinical reports for inclusion in regulatory submissions (e.g., CE Mark, 510K) and to support clinical claims
  • Monitors clinical study compliance
  • Interfaces with investigators, ethics committees and company personnel
  • Plans and conducts clinical investigator meetings
  • Works to ensure rapid and timely approval of products and support of marketing claims
  • Manages CROs
  • Manages Clinical study budgets
  • Negotiates Clinical Contracts
  • Expected to train and mentor others
  • Serve in a project leadership role
  • Knowledge of relevant medical device regulatory requirements (e.g. 510k, PMA, CE)
  • Technical knowledge and skills in clinical trial management for relevant products
  • Works independently on routine tasks
  • Great level of experience in the Clinical Research field
  • Relevant Degree
  • Understanding of GCP
  • Understanding of Clinical Trial Management
  • Understanding of Diabetes (desirable)
  • Understanding of Medical Device Regulations (Desirable)
  • Committed to caring
  • Responsible to our communities
  • Ready to apply our knowledge and know-how
  • Unique in our background and experiences
  • The drivers of our own success
  • Passionate about doing what’s right
20

Clinical Research Associate Resume Examples & Samples

  • Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan
  • Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs
  • Participates in site start up activities as assigned
  • Supervises screening & enrollment at assigned clinical sites
  • Routinely reviews site compliance data and works to identify compliance risks and issues
  • Partners with field staff to develop a CAP to address non-compliance issues as appropriate
  • Manages the completion of assigned project specific deliverables
  • Participate in site close-out activities for assigned clinical sites
  • Partners with colleagues to ensure assigned sites are audit ready at all times
  • Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites
  • Addresses non-compliance issues and trends at investigative site; develops, documents and implements a CAP as necessary
  • Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements
  • Participates as an extended team member of the clinical study team including: participating in study-specific meetings, teleconferences and investigator meetings
  • Conducts device accountability at clinical sites
  • Conducts study specific training for new study coordinators
  • Ensures that all adverse events are identified and clearly documented during visits
  • Serves as a mentor and trainer of junior Field CRA staff
  • Identifies and Reports complaints
  • Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans
  • Ensures training is completed per the required timelines and project needs
  • Identifies process improvement opportunities. Independently proposes solutions/plans
  • Tracks internal process metrics data to measure performance
  • Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
  • 3+ years experience in clinical/scientific research, medical device experience
  • CRM Electrophysiology device study experience preferred
  • Candidate needs to reside in location within reasonable travel distance to the St Louis, MO region
  • Must be able to travel 50-75%
21

Clinical Research Associate Resume Examples & Samples

  • The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports
  • May be responsible for multiple projects and must work both independently and in a team environment
  • Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training. S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed
  • S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues
  • Prepares clinical documents, business correspondence, and procedural manuals
  • Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget
  • Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI 360’s systems and procedures as appropriate
  • Bachelor's Degree or its International Equivalent - Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field; Master's degree preferred
  • Must currently be located in Francophone West Africa
  • French fluency required
  • Must have at least 1 year of clinical research experience
22

Clinical Research Associate Resume Examples & Samples

  • Advanced degree or its international equivalent preferred
  • Supervisory or management experience required
  • Global clinical research work required
  • Spanish and/or French language proficiency strongly preferred
23

Clinical Research Associate Resume Examples & Samples

  • The Clinical Research Associate (CRA)/Zonal Team Leader, monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols
  • Reviews regulatory documents as required and prepares site visit reports
  • Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training
  • S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed
  • S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget. Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI 360’s systems and procedures as appropriate
24

Clinical Research Associate Resume Examples & Samples

  • Educate patients about clinical research protocols, study requirements and expectations
  • Adhere to legal, professional and ethical codes with respect to confidentiality and privacy
  • Collaborate with other members of the research team to ensure consistent practice in patient care management
  • Monitor on-site study sites to meet with, assist and consult with study investigators
  • Recruit and schedule all study site personnel as required
  • Track the expenditures for all study-related activities, including supplies and equipment
  • Create study documents, including protocols and amendments thereof, consent forms, data collections forms
  • Provide inputs to final reports that document the research findings for human use protocols including, but not limited to those listed above
25

Clinical Research Associate Resume Examples & Samples

  • 2-4 years of related experience in scientific research and analysis
  • Familiarity with clinical research methodology is required
  • 1 or more years of experience in direct provision of vestibular testing; experience with equipment such as NeuroCom and Rotary Chair, as well as vestibular rehabilitation techniques
  • Prior experience with participant and/or patient interaction in a clinical setting
  • Ability to follow detailed instructions and standard operating procedures
  • Excellent communication skills (verbal and written) and analytical skills required
  • S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy
26

Clinical Research Associate Resume Examples & Samples

  • Possession of a Bachelor’s degree from an accredited college/university in a field related to biomedical research, clinical trials and/or health or four (4) years related experience in lieu of degree
  • In addition to education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials and monitoring studies at clinical sites
  • Minimum one (1) year of on-site clinical research monitoring of studies for a sponsor or CRO
  • Ability to work in a clinical research setting, both independently and within a team
  • Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines
  • Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
  • Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCPs)
  • Must be detail-oriented with strong organizational skills
  • Knowledge of TrackWise or similar Clinical Trials Management Tracking Systems
  • Ability to travel up to 60% locally, domestically and possibly internationally
  • ACRP Certified CRA or SOCRA Certified Clinical Research Professional
  • Infectious diseases/influenza experience
  • Knowledge of Department of Health and Human Service (DHHS) regulations
  • Experience with the development of CRFs, eCRFs, manual of operations and study monitoring plans
  • Experience with database applications
  • Knowledge of conducting federally funded studies
  • Ability to read and/or speak French or Spanish
27

Clinical Research Associate Resume Examples & Samples

  • A minimum of a Bachelor’s Degree and/or RN Degree is required
  • A minimum of 3 years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required
  • Must have in depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guideline and other applicable regulations and practices is required
  • Working knowledge, understanding and application of principles, concepts and practices of clinical research, experimental design and statistical analysis is required
28

Clinical Research Associate Resume Examples & Samples

  • Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution
  • Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits effective time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits
  • Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
  • Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
  • Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans
29

Clinical Research Associate Resume Examples & Samples

  • Independent clinical monitoring experience
  • Extensive understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines
  • Effective command of written and spoken English language
30

Clinical Research Associate Resume Examples & Samples

  • Communication - Maintains timely and effective communication among team members and site staff. Anticipates/indentifies potential issues
  • Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations. (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor. SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines. and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested; may require guidance to. respond to findings. May be responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities
  • Monitoring - Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements;assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; and regularly reviews the status of the contents within the site regulatory binder
  • Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Utilizes multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
  • Reporting and Tracking - Completes and submits visit reports according to SOP/Works Instructions (WI) requirements. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
  • BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Previous clinical or related research experience preferred. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines; basic knowledge of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Native fluency in Japanese language (speaking, reading and writing) and able to handle business level English
31

Clinical Research Associate Resume Examples & Samples

  • Ability to travel approximately 50% is required
  • 3-4 years experience as a CRA in biotechnology, pharmaceutical industry or CRO
  • Experience in effectively managing multiple tasks and projects
  • Ability to self motivate and work independently to meet timelines
  • Delegates work appropriately
  • Independently develops study documents and processes
  • Demonstrated ability to monitor all visit types independently
  • Understands the needs of stakeholders and able to develop action plans
  • Discerns urgency of issues and takes appropriate action
  • Good working knowledge of ICH & GCP
  • Responsible for the conduct and management of post marketing commitment studies, focusing in the areas of protocol development, study planning and implementation, site monitoring and management, enrollment and data quality
  • Responsible for feasibility assessments for new studies
  • Manages TMF contents and responsible for TMF reconciliation
  • Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.)
  • Responsible for the preparation of study training and investigator meeting materials and presents at study training workshops and investigator meetings
  • Responsible for the development and preparation of study startup, maintenance, and closeout activities, including monitoring plan
  • Responsible for the adherence to timelines, study quality and SOPs for assigned studies
  • Coordinate and complete all operational activities required for the registry startup, ongoing maintenance, and closeout of Medical Affairs (MAF) registry programs
  • Monitoring of registry programs at sites according to the monitoring plan
  • Participate in the selection of CROs and other vendors as needed
  • Responsible for the preparing reports that outline registry progress for both internal and external customers
  • Partner with the MAF team members to anticipate/identify potential problems with registry activities and develop and implement corrective actions to ensure success with these activities
  • Guidance of registry specialist activities supporting MAF programs
32

Senior Clinical Research Associate Resume Examples & Samples

  • Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget
  • Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
  • Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
  • Participate in site qualification and site initiation process, including review of required site documentation
  • Maintain current working knowledge of the disease state & product
  • Assist in training of investigators and coordinators
  • Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues
  • Help with development and oversight of clinical database for the trial
  • May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts
  • Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
  • Coordinate and conduct monitoring visits at participating centers to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
  • Participate in regular project team meetings
  • Minimum of 5+ years experience directly supporting Clinical Research
  • Strong computer skills with a proficiency with MS Windows based applications
  • Strong organizational skills and able to manage multiple tasks
33

Clinical Research Associate Resume Examples & Samples

  • BS / BA in a related scientific or clinical field required
  • Minimum of 3 years related medical device / pharmaceutical field monitoring required
  • Field-based position and ability and willingness to travel up to 75%
  • Excellent interpersonal, problem solving and communication skills
  • Excellent follow-through capability
  • Self-motivated, attention to detail and organizational skills
  • Experience with various computer systems / applications and clinical trial management systems an willingness to learn new systems / databases
34

Clinical Research Associate Resume Examples & Samples

  • Ability to autonomously prioritize workload to meet study timelines while monitoring multiple protocols
  • Perform monitoring visits: Qualify potential investigative site, Train and initiate investigative sites, Conduct routine monitoring visits and close out visits
  • Complete on-time and thorough monitoring trip reports Review case report forms to ensure data compliance
  • Account for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements
  • Ensure site regulatory binder is current
  • Manage investigative sites from study start up through close out
  • Provide support to the investigator evaluation and recruitment process
  • Create telephone scripts, feasibility questionnaires, and / or other related assessment tools for use in site evaluation
  • Assist in the collection of initial regulatory documentation
  • Assist in the preparation of study binders, manuals, or other site specific tools
  • Assist in the review of draft protocols, CRFs, and CRF Completion Instructions
  • Assists in the creation and / or revision of Clinical Affairs Standards and Work Instructions
  • Develop study specific monitoring tools
  • Perform study tracking activities as requested
  • Assist in Development of Clinical Monitoring Plan and / or other study related documents
  • Contribute to internal CRA meetings
  • Proactively identify issues which may interfere with study progress and implement strategies to resolve issues
  • BS / BA in a related scientific area Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment Minimum of 3-6 years of field monitoring experience Medical device experience preferred, but not required Proficient in MS Office Suite of products Experience with Clinical Trial Management System preferred Experience with EDC system preferred Excellent interpersonal and communication skills
35

Clinical Research Associate Resume Examples & Samples

  • Conduct training of investigators and coordinators
  • Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
  • Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
  • Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
  • Develop and maintain current working knowledge of the disease state & product
  • BA/BS or equivalent medical / industry experience
  • Minimum of 2+ years experience directly supporting Clinical Research
  • Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials
  • Previous experience with peripheral vascular devices preferred
  • Previous experience with EDC systems preferred
  • Ability to work effectively on cross-functional teams preferred
  • Valid driver’s license required
  • Able to travel 20% on average and up to 50% during peak periods
36

Senior Clinical Research Associate Resume Examples & Samples

  • Assist clinical team with study start-up activities
  • Thorough understanding of operational aspects of clinical research and regulatory requirements
  • Good interpersonal, problem solving and communication skills
  • Self-motivated, attention to detail and organizational skill
  • Experience with various computer systems / applications and clinical trial management systems; willingness to learn new systems / databases
  • BS/ BA or higher in a related scientific area preferred; a minimum of an RN is required
  • Minimum of 3 years related device / pharmaceutical field monitoring
37

Senior Clinical Research Associate Resume Examples & Samples

  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May represent Regional Associate Directors and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs
  • Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF. Responsible for collecting regulatory documents from site and filing in the Novartis Trial Master File. Prepare and collect study site documents
  • Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism
  • Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTrial Master File webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems
  • Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.)
  • Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of junior CRAs as assigned
  • Manage data query resolution process with sites and track status updates (i.e. IWS)
  • Perform Site Closeout activities per SOPs and applicable regulations
  • Travel domestically (and possibly internationally) as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required
  • Attend and participate in disease indication and project specific training and general CRA training as required
38

Clinical Research Associate Resume Examples & Samples

  • Assist in and participate, plan, and lead study training meetings (e.g., investigator/coordinator meetings)
  • Assist study site staff, investigators, sales representatives, and other staff members regarding investigational products and protocol
  • Cardiovascular device trials
  • Cath lab, operating room and/or intensive care unit familiarity
  • Effective strategic, critical thinking, problem solving skills
  • Knowledge of computerized databases for the maintenance of scientific data
39

Clinical Research Associate Resume Examples & Samples

  • Ensure that all data and data collection from clinical research are handled according to applicable regulations and guidelines
  • Maintain dedicated investigation files to audit and inspection standards
  • Write protocols, amendments, case record forms, clinical reports and other documents relevant for dedicated clinical investigations. This includes ensuring the submission processes (CA + EC/IRB)
  • Ensure that monitoring is performed as planned including start-up and close-out meetings securing a quick start, good quality and adherence to timelines
  • Accountable for the handling of contracts and agreements with investigators, CROs, hospitals and universities
  • Accountable for the preparation, updates and adherence to budget including invoices/payment in dedicated investigations
  • Participate actively in preparing posters, abstracts and manuscripts
  • Coordinate with internal and external stakeholders to bring the investigation from "A to Z" according to plan and budget
  • Prepare and conduct or ensure relevant training for involved people including investigators, nurses, CRAs and other persons within Dentsply Sirona
  • Take part and initiate processes, procedures etc. in order to further develop the skills and capacity of the clinical research team
40

Clinical Research Associate Resume Examples & Samples

  • 3+ years clinical study experience in medical device of pharmaceutical field
  • Working knowledge of Good Clinical Practice (GCP) guidelines
  • Proficient in MS Word, Excel, PowerPoint
  • 6 months + experience with Clinical monitoring procedures
  • Ability to follow U.S. FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards, clinical investigations, monitoring procedures and medical device reporting
  • Ability to travel as needed (25%)
41

Clinical Research Associate Resume Examples & Samples

  • Prepare and execute large scale (100 subject plus) external R&D verification trials –documentation, site training, IRB submission
  • Serve as primary contact for external sites and CRO for all study related questions
  • Monitor EDC production site for open queries and assist external sites in closing them with guidance from EDC programmer
  • Prepare and organize study materials, such as CRF’s and Informed Consent documents
  • Prepare and present training material for external sites
  • Create and submit IRB submissions and close out reports
  • Review and understand study protocol and ensure accurate execution of study procedure
  • Recruit, screen and schedule study patients via e-mail and phone
  • Directly interact with patients in the exam room: obtain informed consent, educate patient on study procedure
  • Assist as necessary in study methodology
  • Collect and enter study data on electronic data capture system and on paper
  • Compile and validate all study data
  • Reconcile study materials
  • Ensure accurate documentation following GCP and GDP
  • Maintain calibration, organization and cleanliness of the research clinic and exam rooms
  • Conduct monthly payroll run with EDC programmer and create purchase orders when needed
  • Perform monthly reclass report and quarterly Sunshine Act report
  • Study tracking and monthly reporting
  • Update and maintain patient database
  • Create and update SOP’s
  • Update and maintain research clinic website
  • Organize efforts and initiatives to attract new patients
  • Associate’s Degree /or Equivalent Education/Training
  • PC Skills (Microsoft Office Proficiency in the following: Outlook, Word, Excel and Internet Explorer)
  • Customer service orientedPreferred Qualifications
  • Microsoft Office Proficiency Access and PowerPoint
  • Experience in a Clinical research-focused environment
  • Health-related training and/or experience
  • Administrative support background
42

Senior Clinical Research Associate Resume Examples & Samples

  • Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments
  • Serves as a consultant in a select area of expertise
  • Obtains and reviews all required essential documents necessary for study initiation
  • Conducts pre-study; initiation; interim; and close-out monitoring site visits and completes site visit reports
  • Maintains accurate and timely sponsor/site correspondence and communication
  • Prepares and presents project progress reports to keep management and team informed
  • Prepares standard the clinical sections of regulatory submissions and international registration packages
  • Coordinates preparation of responses to regulatory agencies’ questions regarding the clinical study
  • Prepares publications; abstracts; or presentations for professional meetings with minimal assistance
  • May advises and trains newly hired CRAs and direct others in the completion of tasks and projects
  • Maintains professional; product; and market expertise via independent reading; networking; and training
  • Volunteers for task forces; manages projects; or serves as a group leader. Encourages collaborative behavior; delegates effectively; and empowers others to take action. Gives effective feedback. Acts with fairness. Actions and words are congruent
43

Clinical Research Associate Resume Examples & Samples

  • Be primary point of contact for sites
  • Build and maintain relationship with sites
  • Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc)
  • Produce monitoring reports within SOP and monitoring plan timelines
  • Coach investigators to be compliant with GCPs and the protocol
  • Talk to site staff about site recruitment
  • Ensure sufficient drug supply on site and reconcile drug on site
  • Ensure high quality data and conduct at sites
  • Identify and escalate issues or concerns to the internal Amicus team
  • Identify, analyze problems and trends; provide and recommend solutions across studies
  • Acts as liaison between CRO CRAs, Field Based CRAs and the PM
  • Accountable for reviewing and approving all trip reports for assigned studies
  • Develop training tools and training materials in support of the project
  • Develop study tools for sites and CRA use
  • Ensure that monitoring visits are performed in accordance with protocol/SOP monitoring plan requirements and that these are tracked, including report status and sign off
  • Accountable for the quality of the trip report content
  • Facilitate the review and provide input to the Monitoring Guidelines
  • Co-monitor with 3rd party CRAs as needed
44

Senior Clinical Research Associate Resume Examples & Samples

  • Lead the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study
  • Conduct and/or oversee clinical monitoring (site qualification, site initiation, interim monitoring, study closeout visits) activities to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. May included monitoring visit report review and/or participating in co-monitoring visits
  • Assist in study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS), study related operational manuals, training materials, and various study plans (e.g., visit logs, monitoring plan, etc.)
  • Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed
  • Collaborate with cross-function study team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and AIRM SOPs
  • Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and. or submission of regulatory documents to the TMF and ongoing document reconciliation
  • Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems
  • Effectively communicate with study team members and work closely with Lead Study Manager to address challenges
  • May participate in process improvement and quality-related initiatives associated with study execution and deliverables
  • Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct
  • Travel Required: up to 25%
  • BA/BS with 4-8 years clinical research experience, or MA/MS with 2-6 years clinical research experience
  • Ability to work independently under general direction in a fast-paced environment
  • Minimum of 2 years prior clinical monitoring experience
  • Must have excellent interpersonal, written, verbal, presentation, administrative and computer skills
  • Moderate (25%) travel required
45

Senior Clinical Research Associate Resume Examples & Samples

  • Serve as clinical contact for a study including CROs/vendors, Investigators and study coordinators
  • Support the Clinical Study Manager and/or Director of Clinical Research with vendor selection and vendor management, including the Contract Research Organization (“CRO”) and other clinical study vendors (Central Lab, IVRS, Scale Management, etc.)
  • In conjunction with the Clinical Study Manager and/or Director of Clinical Research, manage site selection process for clinical studies
  • Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
  • May accompany CRO/CRA’s to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP’s), SOP’s and study protocols
  • Assist in management and oversight of CRO in terms of the approved study budget and compliance to SOPs, and CRO personnel in terms of performance including selection and termination
  • Order and coordinate study supplies for clinical studies
  • Assist in review of vendor contracts and budgets
  • Assist and support data validation and data clean procedures
  • Assure regulatory compliance of investigational sites with SOP's and FDA and ICH
  • Minimum of 8+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
  • Strong, relevant therapeutic experience in pharmaceutical/biotechnology clinical trials
  • Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC); previous experience as a Lead CRA or Clinical Team Lead is highly preferred
  • Experience in leading and working within functional teams
  • Ability to handle and prioritize multiple studies and projects
  • Ability to work effectively in a team/matrix environment
  • Ability to understand technical, scientific and medical information
  • Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
  • Ability to travel up to 25% travel including ground and air
46

Clinical Research Associate Resume Examples & Samples

  • 7+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV, DMD, CRO partnership)
  • Mastery of all site monitoring visits (pre-post) while also understanding that site personnel may require support until lock
  • Extensive knowledge of ICH/FDA guidelines and thorough knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US
  • Thorough knowledge, experience preferred, of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
  • Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes
  • Employs strong fiscal management of departmental budget by independently managing travel and functional expenses
  • Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders
  • Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders
  • Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
  • 1602518
47

Senior Clinical Research Associate Resume Examples & Samples

  • Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; support site identification by conducting feasibility studies as needed; conduct Pre-study Visits for Investigative Sites; effectively facilitate/negotiate contracts for assigned sites within clinical subject budget as needed; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review the investigator study file and reconcile versus the Trial Master File in compliance with GCP/ICH ; perform investigational product accountability and verify storage conditions; coordinate/organize the delivery of supplies as required; validate and track payments to assigned sites and patients travel reimbursement as needed; and conduct Close-out Visits at Investigative Sites
  • Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; assist investigative sites to achieve timely and accurate data entry and resolution of queries; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; ensure issues of data quality are escalated and resolved/followed-up with the study team and CQA, as needed
  • Subject Safety - Monitor the informed consent process; perform safety reviews/SAE reconciliations; verify correct dispensing of IP to subjects; manage Investigative Sites’ adherence to GCP, ICH guidelines and local regulations
  • Train and Assist Investigative Sites - Attend Investigator Meetings, contribute and present when required; train investigative site personnel in GCP/ICH and study-specific requirements and monitor that sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as liaison between Celgene and assigned sites; build effective and positive relationships with site staff at assigned sites
  • Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution/follow-up; create monitoring reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings if applicable; adhere to proper lines of communication within Celgene; attend and participate in study team meetings as assigned; keep information in the CTMS current; maintain calendar
  • Regulatory Documentation - Compile ethics submissions dossier in consultation with the investigator; support and ensure that country specific requirements are obtained when applicable; adapt patient information and consent form to local regulatory requirements to ensure approval; review translations for ICD and study documents as needed; ensure translation and back-translation of study specific documents as required; ensure local requirements are adhered to for EC updates (annual reports, protocol amendments and study completion/termination and safety reports where applicable); maintain local document files at a country level, as needed; liaise with Regulatory Affairs department for submission and any relevant change to be reported to a Competent Authority; maintain study information in the National Trial Database where appropriate
  • Development – Ensure that the medical and clinical knowledge for assigned therapeutic areas is up-to date with the support of line manager; develop and maintain a good working knowledge of relevant protocols; maintain a good working knowledge of FDA, GCP/ICH requirements and relevant regulatory requirements; mentor/coach new CRAs as needed; maintain annual qualification records
  • Examples of Monitoring Lead activities as required locally- serve on study team as monitoring Lead; review RFPs regarding monitoring specifications when required; develop study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; highlight inadequate monitoring resources; track and report critical issues to study team; participate in CRF and protocol review process; conduct CRA/FM meetings
  • Others - Identify/evaluate potential investigators for future Celgene studies; participate and contribute to Clinical Research meetings, cross-functional activities and sharing best practices amongst the team as appropriate; contribute to adequate training of monitors in the study requirements; perform field assessments of Celgene and CRO CRAs, as required; develop study-specific tools for Investigative Sites and CRAs/Field Monitors; CRO monitoring oversight as required; create and review WPs and SOPs if applicable; identify study process improvements
48

Senior Clinical Research Associate Resume Examples & Samples

  • The contractor shall provide oversight and administrative efforts in order to efficiently and effectively monitor the clinical trial process
  • The contractor shall verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents
  • The contractor shall ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA CFR, USAMRMC, OTSG-DA, and DoD, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations
  • The contractor shall lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research
  • The contractor shall conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout trials
  • The contractor shall conduct on-site clinical monitoring that includes; protocol training prior to study start, document reviewing, ensuring accurate data recording, monitoring adverse events, concomitant medications, and inter-current illnesses and verifies they are reported in accordance with the protocol on the Case Report Form (CRF), verify patient data, ensuring adherence to the clinical protocol, site and Sponsor SOPs, investigational product accountability, verification of product shipping/storage conditions, etc
  • The contractor shall conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report
  • SCRAs must work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively
  • The contractor shall prepare trip reports and recommend corrective actions, where appropriate, in accordance with USAMMDA SOPs
  • The contractor will maintain written or email communication as well as telephone communication with the clinical sites. Telephone communications will be documented in minutes
  • The contractor shall participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
  • The contractor shall possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
  • SCRA positions require travel 50-65% of the year
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
  • Must possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies
  • Possess a Bachelor's degree in Science/Health related field or equivalent experience
  • A Master's degree is preferred and will equate to 1-3 years experience
  • Shall possess 7-10 years in clinical trial monitoring
  • Certification as a Certified Clinical Research Profession (CCRP) or Certified Clinical Research Associate (CCRA) is preferred
  • SCRA positions may require travel up to 65% of the year
  • Must provide capability to learn, speak, write, and interpret foreign languages as appropriate
  • Must have the ability to obtain Secret Clearance
49

Clinical Research Associate Resume Examples & Samples

  • Support Clinical Trial Managers by coordinating necessary activities required for setting up investigational sites and monitoring a clinical study, completing accurate study status reports and maintaining study documentation
  • Update clinical trial management systems
  • Initiates, maintains and reconciles the sponsor study files in accordance with Standard Operating Procedures (SOPs)
  • Process site payments
  • Collects and reviews regulatory documents from clinical sites
  • Maintain tracking logs for departmental activities (i.e., training compliance, study related tasks)
  • Provide quality overview and consistency check on all developed ICFs and completes the informed consent checklist
  • 3 year minimum administrative experience
  • 3 or more years of administrative experience in a pharmaceutical or other health related industry, previous on-site monitoring experience preferred
  • Strong organization, time and self management skills
  • Knowledge of ICH/GCP guidelines
  • Ability to working in a team or independetly as required
  • Familiarity with Clinical Trial Management Systems
50

Clinical Research Associate Resume Examples & Samples

  • Regional location (US East Coast, Mid-West [Chicago, Atlanta, Philadelphia, New York City, Boston, Washington, DC, Charlotte)
  • At least four years of experience as a Clinical Research Associate. Experience in the management of multiple sites as a Clinical Research Associate is preferred
  • Excellent verbal and written communication skills, in addition to excellent organizational skills
  • Ability to travel 50% within North America is required
  • Monitoring: Ensures compliance of assigned sites with protocol, regulatory and overall study objectives. Confirms the qualifications of investigators, medical centers, and investigational sites throughout the conduct of a program and assesses adherence to Good Clinical Practice (GCP). Independently monitors clinical study sites: documents all findings, outcomes and agreements reached during site visits. Resolves discrepancies and ensures proper maintenance of site's documentation
  • Participates in co-monitoring visits
  • Participates in study meetings
  • Periodically reviews adverse events reported in the study and works with Pharmacovigiliance colleagues on reconciliation of safety databases. Oversees the required communication to the investigators as per the regulatory guidelines
  • Manages data discrepancies for assigned sties and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution
  • Manages laboratory specimen collection process where applicable including interfacing with laboratory and vendors. Ensures supplies for specimen collection are adequate at the site and site staff is trained on collection and shipment process
  • Identifies problems/issues and reports findings
51

Senior Clinical Research Associate Resume Examples & Samples

  • Minimum 1-2 years experience as a CRA or other related experience in the health care, biotechnology, diagnostics, or other relevant industry; related experience may include clinical trial assistant, project assistant, study assistant or study coordinator
  • Demonstrated competence with Microsoft tools, specifically Word; Excel; PowerPoint; and Project
  • Well-organized and detail oriented
  • Strong oral and written communicator with ability to maintain open communication with internal employees, managers and customers as needed
52

Senior Clinical Research Associate Resume Examples & Samples

  • Attend meetings with CRO and/or vendors and provide input during development or UAT phases
  • Assist in preparation and maintenance of ClinTrials.gov submissions
  • Comply with established company policies and procedures, objectives, quality assurance program, safety, and environmental standards
  • Attend seminars/conferences as required to keep up to date with clinical knowledge
  • Bachelor’s degree in a clinical or health related field, in life sciences, or equivalent work experience. Prefer RN or BSN
53

Senior Clinical Research Associate Resume Examples & Samples

  • 3 years of onsite monitoring experience
  • Experienced in oncology/immunotherapy protocols
  • Strong understanding of ICH GCP Compliance
  • Ability to travel 65-70% of the month
54

Clinical Research Associate Resume Examples & Samples

  • Can conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and transfer data back to Masimo, etc
  • Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision; An advanced individual may conduct more complicated studies, as well as contributes to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects
  • Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects
  • Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used
  • Can effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner
  • Conduct site monitoring (qualification, initiation, monitoring and close out visits) to insure and document site is trained to follow study procedures per protocol
  • Likewise, can monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations
  • Can suggest improvements to departmental procedures relating to GCP monitoring aspects
  • Can understands and operate Masimo products, data acquisition systems, following best practices for execution of study protocol and use of equipment
  • Insure essential study documents are properly organized and stored as quality records
  • Can conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables
  • Writes clear, succinct and detailed clinical study and technical summary reports
  • Ability to travel extensively, perhaps 25-50% of the time, locally and domestically; Travel requirement is subject to change based on business needs
  • Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, and then repack and ship back to Masimo
  • Perform special projects as requested
  • Experienced with Good Clinical Practice (GCP) in conduct of clinical studies
  • Excellent written and verbal communication skills essential
  • Must be capable of interacting with all levels of management, coworkers, investigators and subjects
  • Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing
  • Ability to independently set and manage multiple priorities
  • Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies
  • Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time
  • Ability to lift and carry up to 20 pounds
  • Experience with medical devices
  • Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology)
  • Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements
  • Preferably certified as a Clinical Research Associate
55

Clinical Research Associate Resume Examples & Samples

  • Minimum of 3 years monitoring experience with at least 1 year experience of monitoring Oncology studies in the U.S.A
  • Excellent time management, project management, organizational, and communication skills (written and verbal) ) in local language and English
  • Expertise in and excellent working knowledge of core systems and tools
  • Preferred candidate will reside within the territory
56

Senior Clinical Research Associate Resume Examples & Samples

  • 5 years monitoring experience with at least 3 years experience of monitoring Oncology studies in the U.S.A
  • Possess the ability to work independently and in a team environment
  • Excellent time management, project management, organizational, and communication skills (written and verbal) in local language and English
  • History of strong performance
  • Skills and judgment required to be a good steward/decision maker for the company
  • Possess an excellent working knowledge of all applicable ICH/GCP regulations
  • Preferred candidate will reside within the territory
57

Senior Clinical Research Associate Resume Examples & Samples

  • Manage clinical monitoring activities, including
  • Substantial monitoring experience in clinical research/Clinical Research Organizations
  • Solid understanding of therapeutic indications and study protocol
  • Ability to lead a "virtual" team
  • Competent in written and oral English and local language
58

Clinical Research Associate Resume Examples & Samples

  • Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL’s standard operating procedures
  • Act as PAREXEL’s direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
  • Minimum 2 years of monitoring experience in clinical research
  • Experience with CTMS preferred
59

Senior Clinical Research Associate Resume Examples & Samples

  • Arranging on-site visits and logistics
  • Establishment of a site recruitment plan in collaboration with site staff during QV
  • Performing site documentation verification
  • Data collection and drug accountability in accordance with ICH GCP guideline
  • Monitoring patient safety on-site and addressing any violations in a timely manner
  • Competent in written and oral English and Polish
60

Clinical Research Associate Resume Examples & Samples

  • Assist with development / review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals
  • Assist with the review and analysis of clinical data for clinical trial report generation
  • Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH
  • Act as one of the primary contacts between Seattle Genetics, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Maintain close contact with clinical trial sites
  • Instruct clinical investigators and their personnel in regard to clinical trial protocol regulatory requirements, and with clinical trial specific training
  • Travel alone or with CRO representative to clinical trial sites to monitor compliance with the clinical trial protocol, CFR, GCP/ICH regulations, and overall protocol objectives
  • May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical trial study
  • May perform routine clinical trial site monitoring functions
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant clinical trial management experience
  • Requires strong communication, interpersonal, and organizational skills
  • Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive is preferred
  • Must be willing to travel ( < 10 – 20%)
61

Clinical Research Associate Resume Examples & Samples

  • Serve as primary conduct for managing the relationship with assigned sites on behalf of UTC, cultivating productive relationships and understanding local challenges and opportunities
  • Conduct site evaluation, initiation, monitoring and close out visits
  • Develop and implement study specific monitoring tools
  • Conduct clinical site initiation visits, advise and train site personnel on sponsor and regulatory requirements for study conduct
  • Review on-site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
  • Collect, review and process regulatory documents and correspondence from participating trial sites
  • Provide site support for remote / electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
  • Perform termination of clinical studies through resolving final queries and completing closeout visits
  • Regularly meet with PIs at assigned sites to keep them apprised of issues/concerns affecting the study
  • Gain a working knowledge of the diagnostic / therapeutic field and clinical trial material (CTM) that is to be studied
  • Provide support of CTM activities at site and study level. This may include study drug forecasting, assessing drug supply at clinical sites, reviewing and providing input on IVRS and drug accountability /reconciliation at clinical sites
  • Develop and implement recruitment plans to enhance site enrollment
  • Track personal finances for expense reporting and submission
  • Must be able to submit trip and expense reports in a timely manner
62

Senior Clinical Research Associate Resume Examples & Samples

  • Conduct site evaluation, initiation, monitoring and close‐out visits
  • Provide direction and training for other CRAs assigned to a project or study
  • Drive project success by working closely with CTLs to develop and implement enrollment strategies, monitoring and tracking tools
  • Provide quality accurate review of protocols and Informed Consent Forms (ICFs)
  • Review on‐site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
  • Track subject enrollment and participation at each trial site
  • Maintain tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution. This may include maintaining site information on Clinical Trial Management System (CTMS)
  • Meet with PIs at assigned sites to keep them apprised of issues/concerns affecting the study
  • Respond to site’s questions about EDC use
  • Collaborate with CTL and CRA manager to respond to audit findings at the site level
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • EDC and CTMS experience preferred
  • Knowledge of regulatory and clinical practices (GCP, ICH)
  • Must be able to demonstrate aptitude and knowledge in relevant therapeutic areas and/or ability to learn and integrate new/different therapeutic areas
  • Must be detailed oriented, with strong time management and organization skills
  • Demonstrated ability to successfully perform all aspects of site management
  • Demonstrated understanding of relevant medical / therapeutic knowledge and medical terminology
  • Excellent understanding of Standard Operating Procedures (SOP) and Good Clinical Practices (GCP)
  • Strong interpersonal and written/oral communication skills
  • Understanding of the clinical research process, regulations pertaining to good clinical practice, and the requirements to successfully take a candidate drug through registration
63

Clinical Research Associate Resume Examples & Samples

  • Conduct Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
  • Ensures records are complete and consistent with governing regulations
  • Able to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
  • Assists sites with site-level IRB submissions, queries and documentation
  • Establishes and maintains regular communication with clinical sites
  • Conducts on-site interim site monitoring activities including document review, source data verification, informed consent forms, other site documentation and study material accountability
  • Prepare and complete monitoring visit reports and letters, and effectively document site communications Identify and address routine site issues including protocol deviations, subject recruitment and retention programs and communicate any observed study /data trends and proposed resolution
  • Resolves non-routine site issues in conjunction with the Study Lead
  • Assist with the development of clinical trial documents
  • Ensures distribution, collection, and tracking of regulatory documents to ensure site compliance and audit readiness
  • Assists in the validation and QC of clinical study database(s)
  • Provides input into the development of Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder and other study-related documents as needed
  • Advanced knowledge of clinical trial practices and regulations
  • Advanced knowledge of clinical monitoring and trial design
  • Proficient use of clinical trial databases
  • Proficient knowledge of technical computer systems
  • Willing to travel up to 50%
  • College Degree and minimum of 2-5 years of clinical monitoring experience
64

Clinical Research Associate Resume Examples & Samples

  • Project lead between the Mylan project team (PKDM Department, Product Development Department Chemistry Department, Quality Assurance Department, Mylan affiliate companies and various BD partners), clinical investigators and contract vendors for standard and complex bioequivalence studies
  • Site Manager for 3-4 Bioequivalence (BE) established and new CROs with responsibility to oversee all projects assigned to that CRO. Train new CROs and ensure established CROs are compliant with all study protocols, overall clinical objectives, FDA, ICH and other regional guidance and regulations, internal SOPs and Mylan departmental policies and SOPs. Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for each project
  • Review all clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes review of Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations and Clinical Reports
  • Conduct clinical monitoring of studies remotely and on-site as required according to Mylan Standard Operating Procedures (SOPs). This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations
  • Interview clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any substantial findings to his/her Supervisor during or immediately following a monitoring visit. Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits, as required
  • Assist in management of patient trials and clinical endpoint CRO services related to site management and monitoring functions to include co-monitoring as needed
  • Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience in the field or related experience. However, a combination of experience and/or education will be taken into consideration
  • Certification (i.e., ACRP) as Clinical Research Associate preferred, but not required
  • Must possess knowledge of project management skills and pharmaceutical industry. Knowledge of and understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical trials is required. Knowledge of medical terminology is desired
  • Must possess excellent oral and written communication skills. Good organization skills, attention to detail, ability to work as part of a team and the ability to manage multiple tasks is required. Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines. Should be proficient in PC applications (Excel, Microsoft Word, etc.). Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. The successful candidate must maintain a high level of professionalism and personal integrity
  • Ability to perform computations such as percentages, ratios, and rates. Ability to understand simple statistical analyses
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems
  • Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group or department
  • 30% travel is required to include extended international travel
  • Proficiency in speaking, comprehending, reading and writing English is preferred
65

Lead Clinical Research Associate Resume Examples & Samples

  • Perform all required tasks to ensure study execution under the supervision of the Manager Clinical Field Operations and Clinical Project Managers (CPM)
  • The Lead Clinical Research Associate (LCRA) coordinates and leads Clinical Research Associates (CRA) and sites in EMEAC assigned studies/registries for THV
  • The LCRA ensures that CRA activities are conducted in accordance with the internal quality system and external guidelines and regulations
  • LCRA ensures that the projects are conducted according to protocol and associated documents and that agreed study milestones and timelines will be achieved
  • The LCRA is responsible for the management of day-to-day aspects of study sites and CRA activities for the assigned projects and provides updates to the study team. As key member of the project team, the LCRA supports the development of the Monitoring plan and pays special attention to the adherence of the monitoring plan
  • A higher education degree in a scientific, health care, or other related discipline required
  • Minimum of 5 years field monitoring experience
  • Excellent knowledge of written and spoken English (and local language as applicable)
  • Expertise in communication, managing multiple priorities and computer literacy, supervisory and organizational skills
  • Desirable other European language
  • Understands and can apply knowledge of clinical trial designs to trial execution
66

Clinical Research Associate Resume Examples & Samples

  • 40%: Study Start Up
  • Facilitate CDA & Contract Execution Process (Routing and tracking of study specific contracts)
  • Manage study specific PO Creation
  • Collaborate with Study Manager and CRO to ensure accurate study specific CTMS setup and data feeds
  • Liaise with Transparency group to ensure Clintrials.gov is updated accordingly
  • Participate in creation and distribution of sponsor specific study aides/materials and communications
  • Key point person for R&D select background checks
  • Collate documents required for the EC/IRB/HA submissions
  • 20%: Study Maintenance
  • Assist Clinical Study Manager in tracking study related activities which are not appropriate to be outsourced
  • Agenda distribution & minute taking for internal study team meetings
  • Support SUSAR distribution
  • Maintain internal & external contacts lists in CTMS
  • Facilitate contract execution & study related PO creation for any change orders
  • 25%: Departmental Tasks
  • Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, Sharepoint)
  • Maintain up to date training record attending internal/external training as necessary
  • Participate in inter-departmental workgroups to create or enhance processes
  • Take on career developmental activities/tasks as necessary
  • 15%: Study Close Out
  • Assist study team with preparation for audits/inspections
  • Assist study team in close out in CTMS
  • Liaise with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly
  • Minimum 0-2 year's experience in relevant field (eg. Clinical Site, CRO, Sponsor or Clincal trial Vendor)
67

Clinical Research Associate Resume Examples & Samples

  • You should thrive in project teams and be focused on delivering exemplary levels of customer service
  • You will perform and coordinate all aspects of the clinical monitoring process
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
68

Clinical Research Associate Resume Examples & Samples

  • Clinical research experience in all phases of study life cycle, including start up, interim and close out
  • Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
  • Valid Driver's Licence
  • Valid Passport
  • Demonstrated performance management abilities
  • Extensive monitoring experience
  • Excellent judgment and decision making skills
  • Excellent interpersonal skills and problem solving ability
  • Ability to motivate and integrate teams and teach/mentor team members
  • Able to effectively prioritize workload
  • Knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
69

Clinical Research Associate Resume Examples & Samples

  • A minimum of 18 months on site monitoring experience
  • In depth knowledge of ICH-GCP, EU and FDA requirements
  • Excellent English/Swedish language skills
70

Clinical Research Associate Resume Examples & Samples

  • Fluency in English and in the country's native language
  • Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures
  • Skills to mentor and train other monitors in a positive and effective manner
  • Excellent team player with team building skills
  • Effective presentation skills
71

Senior Clinical Research Associate Resume Examples & Samples

  • Considerable clinical research monitoring experience (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring
  • Expert clinical monitoring skills
  • Fluency in French, both written and spoken
72

Senior Clinical Research Associate Resume Examples & Samples

  • Independently performs monitoring visits, including Pre-Study, Study Site Initiation, routine Monitoring and Study Site Closure visits in accordance to GMCA SOPs and monitoring plan/conventions
  • Documents monitoring activities in monitoring reports and follow-up letters. Communicates serious issues to the study team in a timely manner
  • Serves as point of contact for investigators and site staff and maintains regular contact with study sites to ensure ICH-GCP/Regulatory/Protocol compliance, assessment of subject accrual rates and respond to sponsor/internal team prior, during and following site visits. Works with site personnel and study team to identify resolve and prevent issues
  • Oversees monitoring activities for a study to ensure the accurate reporting of high quality data and timely query resolution; ensure data is collected from sites within given timelines
  • Presents at and participates in Investigator Meetings, other study trainings and meetings as required
  • Ensures quality of data in the event that a site or CRA performance issue has been identified at a previously monitored site
  • Proactively prevents and identifies issues including study processes, monitoring or site issues
  • Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
  • Develops the study Monitoring Plan and ensures CRA compliance with visit frequency and all assigned tasks throughout the study. Escalates CRA noncompliance to Study managers promptly
  • Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
  • Oversees site start-up activities, including site selection and regulatory document collection, review, approval and tracking
  • Develops study specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the life of the project
  • Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., DM Query Trends, Missing CRF pages, Outstanding Monitoring Reports, etc.)
  • Works closely with CSM and other functional groups; collaborates with other departments as required and reports trial site status
  • Works closely with study managers for resourcing issues and to escalate pertinent CRA performance issues when necessary and provides feedback for annual appraisal
  • Assists sites in the preparation of IRB / IEC submissions
  • Works with CSM to manage vendors (e.g. Central Laboratory, CRF printers, Drug Distribution companies, etc.)
  • Works with CSM to assure investigator payments are appropriate and paid on a timely basis (if applicable). Works with CSM to oversee monitoring budget (control time spent onsite, reviewing monitoring reports to be billed on monthly basis)
  • Must have a strong understanding of Medical Terminology, Physiology and Pathophysiology
  • Must be highly organized and able to produce high quality work independently or as part of a team be able to multi-task and work in a high volume, deadline controlled environment
  • Must have an understanding of financial needs and processes (including Clinical budget), revenue forecasting / Recognition and invoicing practice
  • Must have excellent writing, verbal communication, interpersonal and diplomacy skills
73

Clinical Research Associate Resume Examples & Samples

  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
  • Act as a mentor for new clinical staff
  • May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes
74

Clinical Research Associate Resume Examples & Samples

  • We are seeking enthusiastic and motivated individuals who want to stretch themselves in an environment that encourages learning
  • Able to work independently, you will enjoy communicating with others as you will meet a variety of healthcare professionals at monitoring sites, and interact with teams at Quintiles
  • Successful candidates will hold a Degree in a scientific or healthcare discipline and will have monitoring knowledge and strong expertise in a CRO or pharmaceutical environment
  • Experience in oncology is a plus
  • We also require the flexibility to travel up to 60% of the time
  • Fluent English Required (Oral and Written) as well as Computing Knowledge
75

Clinical Research Associate Resume Examples & Samples

  • Reviewing regulatory documents and preparing site visit reports
  • Participating in the study development and start-up processes
  • Reviewing and following study protocols
  • Designing and/or reviewing CRFs
  • Preparing informed consent forms and developing study documents
  • Organizing and presenting at investigator meetings
  • Working with management to develop project-specific CRA training
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • In depth therapeutic and protocol knowledge as provided in company training
  • Strong written and verbal communication skills in Norwegian including a good command of English language
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Bachelor's degree in a health care or other scientific discipline
  • Over one year of on-site monitoring experience
76

Clinical Research Associate Resume Examples & Samples

  • Carry out assigned functions applying knowledge and skill in an accurate, timely manner
  • Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction. Assist in the establishment of procedures and research methodologies
  • Monitor and maintain necessary supplies, with approval by senior department staff
  • Maintain records of activities and notebooks in a professional, accurate manner
  • Writes summary reports and supports protocol development
  • Travel to clinical sites for training, auditing, and closing clinical sites for Alere-sponsored clinical studies
  • Provide recommendations and observations to senior scientific staff on results of projects/tasks
  • Operate equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations
  • Interact with study coordinators at clinical sites to ensure optimal study progression and resolve problems
  • Accurately enter clinical data into a database and identify errors and discrepancies
  • Learn and apply knowledge of statistical methods to analyze clinical data
  • Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
  • Carries out duties in compliance with established business policies
  • Perform other duties & projects as assigned
77

Clinical Research Associate Resume Examples & Samples

  • Conducting clinical monitoring visits, (ie, pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects with a range of travel at 50-75% (approximately 10 days per month, e.g. for assigned site visits, investigator meetings, co-monitoring)
  • Trip report review
  • Attending weekly sponsor/project management teleconferences
  • Involvement in initial review of study documents
  • May present at Investigator's Meetings
  • Monitoring site performance and compliance and providing management with necessary reports, updates, and recommendations
  • Preparing clinical sites for regulatory agency audits
  • Assisting sites and data management with data query resolution
78

Clinical Research Associate Resume Examples & Samples

  • Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May coordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well
  • Travels to field sites to monitor studies and provides technical assistance, when necessary
  • Receives general instructions; plans and prepares studies
  • Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites
  • Assumes responsibility for training and coordinating certification of study site personnel
  • Ensures accurate and complete study management/data collection and transfer to data management
  • Assists, prepares and manages study timelines
  • Conducts reference material testing in-house
  • Participates in Project Team Meetings
  • Keeps informed of trends and developments in clinical research
  • Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity
  • Analyzes alternative approaches to solve problems or develop new perspectives and existing solutions
79

Clinical Research Associate Resume Examples & Samples

  • Manage / Contribute to the study site selection process by preparing feasibility questionnaires and conducting site interviews
  • Organize investigator’s start-up meeting and study site initiation meetings
  • Develop various study specific forms/templates and prepares/ manages study status reports
  • Assist in vendor set-up, and oversight of vendors (including clinical CROs)
  • Review essential documents from study sites for accuracy and completion. Request set-up of TMF and review for reconciliation of required documentation
  • Be the first point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials
  • Conduct monitoring visits and co-monitoring visits: coordinate with clinical investigators in the timely completion, submission, and review of CRFs and verify report data against protocol and patient files
  • Provide support to clinical investigators and study coordinators to resolve site-related issues
  • Communicate all relevant and critical issues to management
  • Assure compliance for assigned projects with clinical research policies and procedures
  • Manage progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Contribute to the review of all SAEs, ensure Medical Director sign-off, site notification and compliance with all company procedures
  • Manage clinical aspects of database lock by participating in data listing review
  • Provide guidance to product supply process and oversee site shipments in alignment with the Clinical supply group
  • Contribute to clinical study design, proposals, and protocols
  • Contribute to patient recruitment strategies to increase patient randomization into the trial (e.g. investigator and research nurse meetings, newsletter updates)
  • Involvement in project follow-up (time planning, budget, project meetings) in collaboration with the CPM
  • Contribute to the Global Project Team for the assigned projects (Core team member)
  • Support junior CRA training
  • Contribute to the improvement of departmental procedures ( eg GCP monitoring aspects etc)
  • Comprehensive knowledge and understanding of Federal and International Guidelines as outlined in Title 21 of the Code of Federal Regulations, and ICH Guidelines of Good Clinical Practices required
  • Has ability to understand the disease under study and the aim of the therapy. Should be able to understand the relevant sections of the study protocol. Monitoring experience preferred
  • Has ability to maintain effectiveness under changing circumstances and priorities and must be able to handle multiple projects at a time and have strong attention to detail while keeping the global picture
  • Must be able to expand knowledge and adapt to an increasingly complex environment
  • Excellent verbal and written communication, presentation, interpersonal and organizational skills required and the ability to build effective relationships with site staff and colleagues
  • Proactive approach, tact and diplomacy strongly required
  • This position requires a sound knowledge of computer software and meticulous attention to detail
  • Must have experience in Electronic Data Capture (EDC) system
  • Should be process-oriented and should demonstrate a sense of urgency in completing deliverables through effective goal setting and a strong result orientation
  • Strong organization, documentation, and interpersonal skills
  • Ability to travel, including air travel, maintaining efficient and effective travel schedules, as the project could involve a lot of traveling, including overnight stays
  • Bachelor’s degree / Master’s degree in scientific discipline or equivalent
  • Minimum of 3-5 years clinical monitoring experience in a pharmaceutical, biotech, or medical device industry
  • Excellent command of spoken and written English / French. Other languages are a bonus
80

Clinical Research Associate Resume Examples & Samples

  • Assist in development of protocol, ICF, CRF, CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools
  • Request and collect initial regulatory documentation
  • Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval
  • Perform study tracking and reports progress in a timely manner
  • Plan and conduct training, site initiation, interim and close-out visits. Complete timely and accurate trip reports
  • Track and account for study devices; assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented
  • Monitor data and follow up with sites regarding timely completion and retrieval of CRFs and data correction forms
  • Assist sites to resolve regulatory document issues; ensure adequate study and regulatory documentation is maintained at the both the investigator site and Bard
  • Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment
  • Communicate findings from contact reports and monitoring visits to Senior Manager and/or Project Manager in a timely manner
  • Initiate and track payments to study sites and external vendors as necessary
  • Experience in monitoring clinical study data and managing site-related issues
  • Knowledge of study protocols and case report forms, trial abstracts, and clinical publications
  • Attention to detail and organizational skill
  • Able to work with little supervision; must be a self-starter
  • Possesses working knowledge of computer/PC skills with experience in Microsoft Word, Excel, Access, Microsoft Project and PowerPoint, network systems (electronic mail) and Clinical Trial Management Systems
81

Clinical Research Associate Resume Examples & Samples

  • Minimum BS in scientific discipline or equivalent. At least 4 years related experience
  • Preferred: BA/BS/Nursing education and/or equivalent clinical research experience, preferably 3-5 years of clinical experience, e.g. CRA in pharmaceutical, biotechnology or medical device company including CRO. In Europe, degree in Biology, Chemistry or other life science, if less than 3 years clinical operations experience
  • Has familiarity with US Federal Food and Drug Administration, ICH/GCP/ISO, and European Regulatory Authority requirements, local regulations (e.g. JP) as applicable to a study
  • Demonstrated proficiency in computer operations in Windows® environment and is able to utilize available software for documents, spreadsheets and electronic mall
  • Must be able to handle multiple projects at a time and must focus on study specific needs while keeping the global picture
  • Excellent verbal and written communication skills required. Able to produce accurate and well-presented documents. Interpersonal and organizational skills are a must. Solution oriented mindset
  • Must be flexible in order to accommodate changes in team and project needs
  • Must enjoy working in global/international teams and be inclusive to others
  • This position is primarily sedentary work with the incumbent working in usual office working conditions with occasional walking/standing and lifting a maximum of 30 lb
82

Clinical Research Associate Resume Examples & Samples

  • Ability to prioritize workload to meet study timelines while monitoring multiple protocols
  • Work with the CRO and help provide documents to the clinical sites
  • Assist in Site qualification telephone calls
  • Assist in Development of Clinical Monitoring Plan and / or other study-related documents
  • Review and process monthly site payments
  • Initial review of AE’s and follow-up with CRO for necessary data for CEC meetings
  • Ability to travel up to 30% domestically
  • Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment
  • Minimum of 5 years of field monitoring experience
  • Medical device experience preferred
  • Proficient in MS Office Suite of products
  • Experience with Clinical Trial Management System preferred
  • Experience with EDC system preferred
  • Additional Desirable Qualifications Skills and Knowledge: Current Certification (CCRA) through ACRP
  • Current Certification (CCRA or CCRP) through ACRP or SOCRA
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Clinical Research Associate Resume Examples & Samples

  • Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation
  • Identify potential investigators, prepare site budgets and contract agreements
  • Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
  • Assist with the management of key study parameters (i.e. trial master files,