Regulatory Affairs Jobs at Ohio State University
Step into a pivotal role in clinical research with one of the most respected healthcare institutions in the world. This remote job opportunity in regulatory affairs empowers Life Science professionals to support high-impact clinical trials while advancing global research standards. At The Ohio State University Wexner Medical Center, this position is ideal for ambitious candidates seeking Jobs in USA that combine scientific rigor, policy understanding, and operational excellence—making it a top choice for Jobs for Life Science GRADUATES entering the regulatory field.
About the University
The Ohio State University Wexner Medical Center is home to one of only 50 National Cancer Institute-designated comprehensive cancer centers. Through the Arthur G. James Cancer Hospital and the Solove Research Institute, the institution leads groundbreaking research across laboratory, clinical, and population sciences. Its mission is to prevent, diagnose, and treat cancer with innovative approaches—making it an exceptional environment for those pursuing regulatory affairs jobs or a future as a regulatory compliance officer.
Job Details:
- Job Title: Regulatory Compliance Officer – Clinical Trials Office (CTO)
- Location: Remote (Home Office, OH)
- Job Number: R141528
- Type: Full-time
Position Summary
The Regulatory Compliance Officer ensures that OSUCCC Clinical Trials Office (CTO) research protocols comply with University, state, and federal regulations. This role supports the timely submission, review, and maintenance of regulatory documentation across assigned clinical trials.
Responsibilities
- Collaborate with investigators during study development to ensure appropriate regulatory safeguards.
- Conduct detailed regulatory reviews of protocols and informed consent forms prior to IRB submission.
- Ensure timely submission of documents to regulatory agencies and communicate with sponsors (academic, federal, and industry).
- Coordinate with internal and external groups to compile and manage data required for CTO trials.
- Prepare IRB submission packets, including abstracts, standard forms, and informed consent drafts.
- Maintain tracking systems to monitor protocol review progress and regulatory essential files.
- Review protocol amendments, revise consent forms, and determine the need for IRB review per guidelines.
- Distribute amendments and IRB-approved consent forms to university protocol holders.
- Serve as the primary point of contact for the dissemination of approved study materials.
- Communicate updates effectively across internal and external stakeholders.
- Attend meetings and act as primary CTO contact with regulatory bodies (FDA, IRBs).
- Monitor federal and sponsor regulations to identify and interpret new or updated requirements.
- Provide regulatory updates and guidance to investigators and research staff.
- Participate in audits and site visits.
Regulatory Affairs Job Requirements
- Bachelor’s degree in biological sciences, or equivalent education/experience.
- Minimum 1 year of experience in a research or administrative role supporting research projects.
- Knowledge of research regulations, guidelines, and compliance requirements.
- Experience in preparing informed consent forms and regulatory documents preferred.
- Familiarity with IRB processes and federal/industry sponsor requirements strongly preferred.
