Job Opportunities API

University of California, Irvine is hiring a Quality Assurance Coordinator. The role involves conducting and assisting internal quality assurance monitoring and auditing activities for clinical research studies within the Chao Family Comprehensive Cancer Center, ensuring regulatory compliance, data integrity, and participant safety. The coordinator also leads external audits and manages corrective and preventive actions related to audits. Highlights • Conduct internal quality assurance monitoring and auditing of clinical research studies, focusing on regulatory compliance, data accuracy, and participant safety. • Review informed consent processes, eligibility, electronic medical records, adverse events, and Investigational Drug Service/pharmacy records. • Coordinate and communicate with auditors, research staff, and oversight committees during external audits. • Oversee the corrective and preventive action (CAPA) process to ensure implementation and effectiveness. • Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and clinical research methodologies. • Experience with clinical trial data review and submission verification across Phases I, II, and III. • Proficiency with Microsoft Office suite and adaptability to new software and web tools. • 3-5 years of related clinical research experience, preferably with cancer-related research or FDA-regulated complex trials. • Preferred certification from SoCRA, ACRP, or similar professional bodies. • Hourly pay range from $33.04 to $57.88, full-time employment with access to benefits including medical insurance and retirement plans.