The Dragoo Research Program, located at the Inverness Orthopedics and Spine Center - Steadman Hawkins Clinic, is seeking a Senior Clinical Research Coordinator (Sr. CRC) with clinical research experience. The Sr. CRC role requires proficient communication with several entities, physicians, and researchers, as well as leading clinical trials and regulatory requirements for human subject research.
The Sr. CRC will be responsible for maintaining a thorough understanding of assigned human subject research protocols and projects, particularly focusing on the biobanking initiative (CUREBANK), investigator-initiated studies, and industry-sponsored research. The Sr. CRC will report to the Program Manager and provide technical and administrative assistance to Dr. Jason Dragoo’s research team. Duties include engagement in technical research activities, laboratory functions, data entry and oversight using electronic systems, and ensuring compliance with reporting requirements for protocols and projects.
Key Responsibilities:
- Updates study calendar of various clinical protocols and coordinates logistics needed for successful completion of the studies.
- Serve as a primary contact for regulatory bodies, study participants, Sponsors, and fellow researchers, handling tasks such as scheduling, confirming appointments, etc.
- Screens, recruits, and obtains informed consent from potential candidates for research studies.
- Coordinates study clinic visits, and performs protocol-specific research activities including, but not limited to, concomitant medicine checks, physical histories, AE/SAE/UAP checks.
- Ensures compliance with applicable regulations at the federal, state, and local levels.
Complies with institutional and external clinical research requisites and manages Internal Review Board (IRB) documents and other regulatory materials, such as applications, informed consent, and HIPAA consent forms and documents. Conducts training sessions and updates to other research staff, investigators, and clinical staff.
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