Regulatory Compliance Officer – Clinical Trials
The Ohio State University, Main Campus
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Junior
About the role
- Assures that research protocols of the OSUCCC Clinical Trials Office (CTO) are in compliance with University, state and federal regulations
- Ensures timely submission of all appropriate paperwork for review by appropriate agency
- Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included
- Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review
- Communicates with all CTO research projects sponsors to ensure compliance
- Develops IRB submission packets for protocols, including writing of abstract and drafting of informed consent forms
- Attends meetings; serves as principal contact from CTO to regulatory agencies including FDA and IRBs
- Provides regulatory updates and guidance to investigators and research staff of new or changed regulations
Requirements
- Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required
- One 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
Benefits
- Health insurance
- Tuition assistance for employees and their dependents
- State or alternative retirement options with competitive employer contributions
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceIRB submissioninformed consent developmentprotocol reviewresearch documentationabstract writingregulatory updatesresearch project managementfederal regulationsguidelines compliance
Soft skills
collaborationcommunicationorganizational skillsattention to detailproblem-solvinginterpersonal skillsleadershiptime managementadaptabilitycritical thinking