Senior Quality Assurance Coordinator

🇺🇸 Orange, CA 🕑 Full-Time 💰 $79K - $143K 💻 Quality Assurance 🗓️ April 19th, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Senior Quality Assurance Coordinator. The role involves conducting internal quality assurance audits and monitoring for clinical research studies, focusing on regulatory compliance, subject safety, and data integrity. The coordinator also leads external audits, manages communication among stakeholders, and oversees corrective actions for clinical trials.

Highlights

Conduct internal audits and monitoring of clinical research studies under CFCCC.
Ensure compliance with protocols, federal regulations, and university policies.
Review informed consent, eligibility, adverse event documentation, and pharmacy records.
Lead and coordinate external audits and facilitate communications with auditors and institutional offices.
Oversee corrective and preventive action (CAPA) processes to ensure effective implementation.
Require knowledge of GCP, ICH guidelines, and clinical trial data review across multiple therapeutic areas.
Proficiency in Microsoft Office and ability to learn new software quickly.
Bachelor's degree or equivalent experience with 3-5 years in related field, preferably oncology clinical trials.
Salary range from $79,200 to $143,400 per year, with benefits including medical insurance and retirement plans.
Experience with FDA-regulated, high complexity clinical trial monitoring or auditing is required.