Regulatory Compliance Officer - Clinical Trials Office
Remote · United States
Job Summary
Regulatory Compliance Officer for the Clinical Trials Office at The Ohio State University Comprehensive Cancer Center. Responsible for ensuring research protocols comply with university, state, and federal regulations; coordinating timely regulatory submissions; drafting IRB-related documents including abstracts and consent forms; maintaining regulatory files; communicating with CTO sponsors and internal/external stakeholders; coordinating data relevant to CTO trials; developing IRB submission packets; tracking protocol progress; distributing amendments and approved consent forms; serving as liaison to regulatory agencies (FDA/IRBs); staying updated on new regulations and conducting audits/site visits; providing regulatory guidance to investigators and staff.
Required Qualifications
- Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience
- 1 year experience in research or administrative capacity working on research projects
- knowledge of research regulations, guidelines and compliance issues required
- experience developing informed consent documents and preparing regulatory documents desired
- experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred
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