The Regulatory Compliance Officer provides regulatory expertise to ensure research protocols comply with university, state, and federal regulations across research groups managed by the College of Medicine Center for Clinical Research Management (CCRM). Participates in the development and implementation of strategies, policies, and procedures to ensure proposals meet or exceed federal, state, and local regulations. Develops and prepares protocol submissions to local and national Institutional Review Boards (IRB), including writing of abstract, submission of standard forms, and drafting of informed consent form. 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. Ensures timely submission of protocol documents for review by appropriate agency. Communicates with sponsors of any research project (industry, federal, collaborative, investigator-initiated) to address concerns and assure compliance. Establishes and oversees tracking system to continually monitor progress of protocol review and status of approval. Reviews and authorizes protocol revisions and amendments. Amends consent forms as needed and follows established guidelines from OSU and NIH (National Institutes of Health) to determine if amendment requires IRB review. Distributes amendments and IRB approved informed consent forms to relevant university protocol holders. Continually monitors federal and sponsor rules, regulations, and processes to identify and interpret new, updated, or changed requirements. Provides regulatory updates to investigators and research staff of new or changed regulations. Participates in audits and site visits.
Minimum Education Required: Bachelor's Level Degree or equivalent combination of education and experience.
Required Qualifications: 2 years of relevant experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required.
Desired Qualifications: 2-4 years of relevant experience preferred. Experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired.
Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.
This position is primarily remote; however, there may be times when being onsite may be required.
Location: Davis Heart and Lung Research Institute (0113)
Position Type: Regular
Scheduled Hours: 40
Shift: First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
The university is an equal opportunity employer, including veterans and disability.
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