Grant Funded Department of Medicine Clinical Research Unit - Clinical Research Coordinator I
About The Position
Under general supervision of the Principal Investigator, the Clinical Research Coordinator I assists with administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. This role involves recruiting, screening, and enrolling eligible study participants, obtaining informed consent, and managing study-related documentation. The coordinator will communicate with sponsors, IRBs, and other departments to ensure smooth protocol implementation and maintenance, assist in monitoring enrollment goals, and coordinate tasks such as developing informed consents and screening materials. They will collect data from various sources, process and ship research specimens, ensure compliance with protocols and regulatory agencies, track and report adverse events, and coordinate site monitoring visits. Additionally, the role involves preparing and submitting regulatory documents, maintaining patient databases and study logs, and obtaining phlebotomy training to assist with specimen collection and processing.
Requirements
- Bachelor's Degree required.
- Bachelor's degree in science or a related field required.
- Three (3) years experience in clinical research may be substituted for education.
- 1 year in healthcare or research preferred.
- IATA required with hire.
- Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment.
- Knowledge of medical and/or pharmaceutical terminology strongly desired.
- Strong organization and communication skills required.
- Able to work with multiple interruptions and to perform multiple tasks at any given time.
Responsibilities
- Recruit, screen, and enroll eligible study participants.
- Obtain informed consent from study participants.
- Manages completion and submission of study related documentation.
- Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
- Assist in monitoring enrollment goals.
- Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
- Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
- Collect, process, and ship research specimens as directed in the protocol.
- Ensure compliance with study protocol and requirements of regulatory agencies.
- Tracks and reports adverse events and protocol deviations.
- Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
- Under supervision, prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
- Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log.
- Will obtain phlebotomy training within 90 days of hire and assist with the collection and processing of various research specimens.
Benefits
- Comprehensive Medical, Dental, & Vision Benefits
- Employer Funded Pension Plan, vested after five years (Voluntary 403B)
- Paid Time Off (accrued from day one)
- Onsite fitness studios and discounts to our Carilion Wellness centers
- Access to our health and wellness app, Personify Health
- Discounts on childcare
- Continued education and training
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
