Regulatory Compliance Assistant

The Ohio State University

2d • Hybrid

About The Position

The Regulatory Compliance Assistant provides support to ensure research protocols comply with university, state, and federal regulations for research groups managed by the College of Medicine’s Center for Clinical Research Management (CCRM). This role involves assisting with regulatory functions for clinical research activity, preparing protocol submissions to Institutional Review Boards (IRBs), and providing updates on submission status. The assistant also helps prepare other required regulatory documents, distributes approved documents, and relays information to clinical research staff. Key tasks include data entry, maintaining data and documents in the OnCore electronic database and e-Regulatory system, assisting with monitoring visits and regulatory issues, and creating and maintaining regulatory files. This is a hybrid position, allowing for remote work for most duties, but may require occasional office visits for training or meetings. It is a regular, full-time position with 40 scheduled hours on the first shift.

Requirements

• High School diploma or GED
• 1 year of relevant experience

Nice To Haves

• Certification or vocational training may be preferred
• Bachelor's degree, preferably in biological sciences, health sciences, or life sciences
• 2-4 years of relevant experience
• Experience in a clinical research capacity
• Computer skills with knowledge of database software applications

Responsibilities

• Provide support to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine’s Center for Clinical Research Management (CCRM)
• Assist with regulatory functions in support of clinical research activity
• Assist in preparation of protocol submissions to Institutional Review Boards (IRBs)
• Provide updates on submission status
• Assist in preparation of other required regulatory documents
• Distribute approved documents
• Relay information to clinical research staff
• Assist with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database and e-Regulatory
• Assist with monitoring visits
• Assist with regulatory issues
• Create and maintain regulatory files

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost
• Paid time off, including sick and vacation time and 11 holidays
• State retirement plan or an alternative retirement plan, both with generous employer contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees