Regulatory Assistant - Clinical Trials Office

Position Summary

Regulatory Assistant to provide support to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the Clinical Trials Office (CTO).

Responsibilities

• Affords support to regulatory functions in support of clinical research activity.
• Affords assistance in preparing protocol submissions to Institutional Review Boards (IRBs) and provides updates on submission status.
• Affords assistance in preparing other required regulatory documents.
• Distributes approved documents.
• Relays information to clinical research staff.
• Affords assistance with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database.
• Affords assistance with monitoring visits.
• Affords assistance with regulatory issues.
• Creates and maintains regulatory files.

Job Requirements

• Bachelor's degree, preferably in biological sciences, health sciences, or life sciences or equivalent combination of education and experience required;
• Experience in a clinical research capacity desired;
• Computer skills required with knowledge of database software applications desired.