Fay Agyepong
@fayagyepong
Detail-oriented Clinical Research Coordinator with GCP training.
What I'm looking for
I am a detail-oriented Clinical Research Coordinator with over 2 years of experience in supporting IRB submissions, regulatory documentation, and protocol compliance across multi-site clinical trials. My expertise lies in managing Investigator Site File (ISF) documentation, adverse event reporting, and ensuring audit readiness. I have a proven track record of collaborating effectively with sponsors, Principal Investigators (PIs), and Institutional Review Boards (IRBs) to maintain compliance with FDA, DHHS, and ICH-GCP standards.
Currently, I work at Atrium Health Wake Forest Baptist, where I prepare and submit IRB regulatory packets, maintain audit-ready documentation, and coordinate with central labs for biological sample shipments. My role involves meticulous version control and supporting cross-functional trial teams to ensure quality assurance throughout the trial lifecycle. I am now seeking to transition into a regulatory-facing role to further advance trial compliance and oversight.
Experience
Work history, roles, and key accomplishments
Clinical Research Coordinator
Atrium Health Wake Forest Baptist
Jul 2023 - Present (2 years 1 month)
Prepared and submitted IRB regulatory packets for initial site submissions, amendments, and continuing reviews, ensuring accurate documentation, version control, and compliance with institutional and protocol-specific guidelines. Maintained and organized audit-ready investigator site files (ISF), digital folders, and regulatory trackers for multi-site and cardiovascular device studies; supported s
Administrative Coordinator
Palladium Primary Care
Sep 2022 - Jun 2023 (9 months)
Facilitated seamless communication between patients and cross-functional clinical teams, improving response times and contributing to a smoother patient journey during clinic visits. Provided administrative support with precision, gaining hands-on experience with clinical billing workflows and aligning patient services with effective cost-tracking requirements.
Education
Degrees, certifications, and relevant coursework
University of North Carolina-Greensboro
Bachelor of Science, Biochemistry
2017 - 2021
Obtained a Bachelor of Science with a major in Biochemistry. The curriculum provided a strong foundation in scientific principles and laboratory techniques.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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