University of California, Irvine is hiring a Quality Assurance Coordinator. The role involves conducting and assisting with internal quality assurance monitoring and auditing activities for clinical research studies, ensuring regulatory and protocol compliance, overseeing external audits, and managing corrective and preventive action processes.
Highlights
Conduct internal quality assurance monitoring and audits for clinical research studies within the Chao Family Comprehensive Cancer Center.
Review regulatory compliance, subject management, data integrity, and Investigational Drug Service/pharmacy research activities.
Lead coordination of external audits and facilitate communication between auditors, research staff, and institutional committees.
Oversee corrective and preventive action (CAPA) processes to ensure implementation and effectiveness.
Strong knowledge of GCP, ICH guidelines, and clinical trial phases I-III across multiple therapeutic areas required.
Proficient in Microsoft Office suite with ability to quickly learn new software and web interfaces.
Requires 3-5 years of relevant experience with a Bachelor’s degree or equivalent.
Preferred certifications include SoCRA, ACRP, or related professional certifications; experience with FDA-regulated and cancer-related clinical trials.
Salary range: $33.04 to $57.88 per hour.
Requires access to transportation for travel to campus and satellite work sites.