Regulatory Affairs Coordinator

🇺🇸 Orange, California 🕑 Full-Time 💰 $38 - $62 per Hour 💻 Compliance 🗓️ November 2nd, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Regulatory Affairs Coordinator. The role involves managing and overseeing regulatory aspects of clinical trials within the UCI Center for Clinical Research, ensuring compliance with regulatory requirements, coordinating study documentation, and maintaining communication with regulatory agencies and study teams.

Highlights

Manage and conduct multi-phase clinical research protocols from initiation to completion.
Ensure compliance with regulatory requirements for human subject studies, including IRB, FDA, and sponsor reporting.
Lead study-related meetings and maintain investigator site files and clinical trial documentation.
Use clinical trial management system (OnCore) for accurate record-keeping.
Required skills include experience with IRB submissions, Microsoft Office Suite, Zoom, and strong communication skills.
Minimum of 3-5 years related experience as a regulatory affairs coordinator or assistant with a Bachelor's degree or equivalent experience.
Preferred knowledge includes federal, state, and local clinical trial regulations, various clinical trial types, and certifications such as ACRP, SoCRA, or CCRP.
May require work outside normal business hours and travel to off-site research locations.
Hourly pay range is USD $37.56 to $61.91.
Works closely with clinical research teams, regulatory bodies, and sponsor monitors within a large university medical research setting.