Description
The Clinical Research Protocol Coordinator provides clinical trials regulatory support for the Center for Cancer and Immunology Research department, including specific groups as assigned. The Clinical Research Protocol Coordinator will work with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, problem reports, including all necessary forms. Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents. Review and ensure that protocols and informed consents meet regulatory requirements and are written in a format compatible with the guidelines. Work with research teams to prepare submissions to the appropriate regulatory bodies (e.g. Institutional Review Board, Data and Safety Monitoring Entity, etc.,). Collaborate with staff on IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Manage, track and coordinate regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closures. Help CRCs to maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. Work with PI and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies as needed.Qualifications
Minimum Education
Bachelor's Degree In health sciences, clinical research or applicable discipline.
Knowledge of the biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred.
(Required)
Master's Degree (Preferred)
Work requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research.
Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required
Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).
Previous experience with investigator-initiated or pharma-sponsored clinical trials required
(Required)
Protocol and Regulatory Development
Regulatory Filing and Reporting
Program Coordination
Quality Assurance
Analysis
Teamwork/Communication
Performance Improvement/Problem-solving
Cost Management/Financial Responsibility
Safety
CN Hospital (Main Campus)
111 Michigan Avenue NW
Washington 20010
Position Status : R (Regular)- FT - Full-Time
Shift : Day
Work Schedule : 9:00-5:30 PM
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