Temporary Clinical Research Regulatory Coordinator

🇺🇸 Orange, California 🕑 Temporary 💰 $38 - $62 per Hour 💻 Compliance 🗓️ September 11th, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator. The role involves managing the regulatory lifecycle of clinical research studies, maintaining compliance with FDA and institutional requirements, and preparing for sponsor monitoring visits, audits, and inspections.

Highlights

Manage regulatory lifecycle stages including IRB submissions, continuing reviews, amendments, and study closeout.
Maintain regulatory documentation such as informed consent forms, HIPAA authorizations, and electronic binders (Complion, OnCore).
Collaborate with principal investigators, study teams, sponsors, and regulatory agencies to resolve regulatory issues and manage protocol deviations and serious adverse events.
Lead regulatory readiness for audits, sponsor monitoring visits, and inspections by maintaining audit-ready documentation and supporting quality initiatives.
Required bachelor's degree or equivalent experience and 3–5 years of regulatory experience in clinical research.
Strong knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and Phase I–III drug/device clinical trial requirements.
Preferred experience with electronic clinical research systems like OnCore and Complion and preparing for regulatory inspections and audits.
Compensation ranges from $37.56 to $61.91 per hour.
Ability to manage multiple regulatory projects independently and use medical terminology effectively in a clinical research setting.
Temporary full-time position with access to benefits including medical insurance, paid vacation, and retirement savings plans.