Regulatory Compliance Assistant

Job Description Summary

Regulatory Compliance Assistant to provide support to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicines Center for Clinical Research Management (CCRM); assists with regulatory functions in support of clinical research activity; assists in preparation of protocol submissions to Institutional Review Boards (IRBs) and provides updates on submission status; assists in preparation of other required regulatory documents; distributes approved documents; relays information to clinical research staff; assists with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database and e-Regulatory; assists with monitoring visits; assists with regulatory issues; creates and maintains regulatory files.

Minimum Education/Experience Required

High School diploma or GED. Certification or vocational training may be preferred. 1 year of relevant experience required.

Education/Experience Preferred

2-4 years of relevant experience preferred. Bachelor's degree, preferably in biological sciences, health sciences, or life sciences or equivalent combination of education and experience preferred; experience in a clinical research capacity desired; computer skills required with knowledge of database software applications desired.

Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.

FUNCTION/SUBFUNCTION: Research Administration/Research Compliance

CAREER BAND: Technical-Individual Contributor

CAREER LEVEL: T2

This position is hybrid and is primarily remote; however, there will be times when working from the office will be required.