Clinical Research Coordinator
3 weeks ago
Cape Fox Federal Contracting Group is seeking a highly skilled Clinical Protocol Coordinator to join our team in Bethesda, MD in support of the NIH.
Responsibilities:- Assist researchers with protocol development, assembly, and review of clinical trial documents.
- Develop, prepare, and review internal research proposals, abstract submissions, poster presentations, and manuscript drafts.
- Develop protocol documentation, including schemas, patient calendars, and teaching aids.
- Develop clinical research informed consent and other ethics and regulatory related documentation.
- Prepare study reports and status updates, including amendments, audits, and other administrative documentation.
- Assist researchers to develop initial and amended clinical research protocols and related documentation throughout the lifecycle of the study.
- Develop and maintain trial-related documents and operational procedures.
- Collect, organize, and maintain all study documentation, including investigator qualifications, trial logs, and safety reports.
- Maintain accurate records of all protocols and study applications, safety reports, annual reports, and correspondence.
- Write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
- Prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
- Maintain all regulatory trial documentation, including maintaining a complete and up-to-date Regulatory Binder for each trial.
- Collect and distribute regulatory documents.
- Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
- Organize quality assurance activities with pertinent regulatory bodies, such as audits by FDA, NIH, pharmaceuticals, and others.
- Prepare researcher communication with IRB and NIH Clinical Center for protocol approval.
- Prepare submission documentation for regulatory bodies in support of clinical trials.
- Manage, track, and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
- Masters degree in Health Medical Professions, Nursing, Biology, Multi-disciplinary, or General Science.
- Expert writing skills required for clinical research protocol and informed consent document development.
- IRB submissions, regulatory document management, and other regulatory study tasks.
- Clinical research-related certifications preferred.
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