Clinical Research Coordinator - Grant Funded - Department of Medicine Clinical Research Unit
- 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.
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