Temporary Clinical Research Regulatory Coordinator

🇺🇸 Orange, CA 🕑 Temporary 💰 $38 - $62 per Hour 💻 Compliance 🗓️ July 19th, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator. The role involves independently managing the regulatory lifecycle of clinical research studies, preparing and maintaining regulatory documentation, collaborating with study teams and regulatory agencies, and ensuring compliance with regulatory requirements through audit readiness and quality improvement.

Highlights

Manage study activation, IRB submissions, continuing reviews, amendments, reportable events, study closeout, and document archiving for clinical trials
Prepare and maintain regulatory documents such as informed consent forms, HIPAA authorizations, electronic regulatory binders (Complion), and OnCore records
Collaborate with principal investigators, sponsors, and regulatory agencies to resolve compliance issues and manage protocol deviations and serious adverse events
Lead regulatory readiness for sponsor monitoring visits, audits, inspections, and quality improvement initiatives
Required knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and regulatory requirements for Phase I–III clinical trials
Minimum 3–5 years of clinical research regulatory experience and bachelor's degree or equivalent combination of education and experience
Preferred experience with electronic clinical research systems like OnCore and Complion
Strong analytical, communication, and presentation skills to support report generation and process improvements
Pay rate ranges from $37.56 to $61.91 per hour
Temporary full-time position with benefits including medical insurance, paid vacation, holidays, and sick leave