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University of California - Irvine

Assistant Regulatory Affairs Coordinator - Hybrid

🇺🇸 Hybrid - Orange, CA 🕑 Full-Time 💰 $31 - $51 per Hour 💻 Compliance 🗓️ July 23rd, 2026
IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring an Assistant Regulatory Affairs Coordinator to support the clinical research efforts at the Chao Family Comprehensive Cancer Center. The role involves managing regulatory submissions and maintaining compliance for cancer-related protocols, interacting with regulatory committees and sponsors to facilitate clinical trial activation and ongoing regulatory communication.

Highlights
  • Manage submissions of modifications, renewals, adverse events, and study closures to IRB, FDA, and other institutional committees.
  • Serve as liaison to sponsors, regulatory agencies, and research groups including NCTN and pharmaceutical companies.
  • Maintain regulatory information in the clinical trial management system (OnCore) and adhere to Cancer Center Support Grant reporting guidelines.
  • Required skills include strong communication, problem-solving, prioritization, discretion, and ability to work independently and in teams.
  • Experience with institutional research committee submissions and 1-3 years of related coordination experience with a bachelor's degree or equivalent.
  • Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint) required.
  • Preferred qualifications include experience with cancer-related research, knowledge of human subject clinical trials, and familiarity with OnCore.
  • Salary range from $31.11 to $51.25 per hour with comprehensive benefits including medical insurance and retirement plans.
  • May require work outside normal business hours and travel to satellite sites.
  • Commitment to confidentiality, adherence to university policies, and ability to work with diverse populations expected.