Regulatory Compliance Officer - Cancer Trials
About The Position
The Regulatory Compliance Officer assures that research protocols of the OSUCCC Clinical Trials Office (CTO) comply with University, state, and federal regulations and ensures timely submission of appropriate paperwork for review by the appropriate agency. The role works with investigators and sponsors, prepares and reviews protocol and informed-consent materials, and maintains regulatory tracking and files for clinical trials. This position is primarily remote. New employees must attend in-person training and orientation during onboarding. After onboarding, occasional in-person activities may include meetings, audits, monitoring visits, and site initiation visits.
Requirements
- Bachelor’s degree in biological sciences, health sciences, social sciences, or another medical field, or an equivalent combination of education and experience.
- One year of experience in a research or administrative capacity working on research projects.
- Knowledge of research regulations, guidelines, and compliance issues.
Nice To Haves
- Experience developing informed consent documents and preparing regulatory documents.
- Experience and knowledge of IRB and federal or industry sponsor processes and requirements.
Responsibilities
- Collaborate with investigators during study development to facilitate and confirm that appropriate regulatory safeguards are included.
- Conduct detailed reviews of assigned protocols and informed consent forms before IRB review.
- Ensure timely submission of protocol documents to the appropriate agency and communicate with CTO research project sponsors to ensure compliance.
- Interface with internal and external entities to coordinate and compile data relevant to the conduct of CTO trials.
- Develop IRB submission packets, including writing abstracts, submitting standard forms, and drafting informed consent forms.
- Provide and maintain a tracking system to assess protocol review progress and maintain regulatory essential files on submitted and approved studies.
- Review protocol revisions and amendments, amend consent forms when needed, and determine according to established guidelines whether amendments require IRB review.
- Distribute amendments and IRB-approved informed consent forms to relevant university protocol holders.
- Serve as the main point of contact for disseminating approved study materials and collaborate with internal and external departments to communicate updates effectively and promptly.
- Attend meetings and serve as the CTO's principal contact with regulatory agencies, including the FDA and IRBs.
- Monitor federal and sponsor rules, regulations, and processes to identify and interpret new, updated, or changed requirements.
- Provide regulatory updates and guidance to investigators and research staff and participate in audits and site visits.
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What This Job Offers
Job Type
Full-time
