University of California, Irvine is hiring a Senior Quality Assurance Coordinator. The role involves conducting internal quality assurance audits and monitoring clinical research studies to ensure regulatory compliance, data integrity, and participant safety. The coordinator also leads external audits, coordinates communications among stakeholders, and oversees corrective and preventive actions for clinical trials within the cancer center.
Highlights
Conduct internal audits and monitoring for clinical research studies at all CFCCC participating sites.
Review regulatory compliance, data accuracy, subject management, and Investigational Drug Service Pharmacy activities.
Lead and coordinate external audits; communicate with auditors, research staff, and institutional committees.
Oversee corrective and preventive action (CAPA) process for audit findings.
Ensure compliance with protocols, SOPs, GCP, federal regulations, and university policies.
Proficient with Microsoft Office; ability to quickly learn new software tools.
Requires bachelor's degree and 3-5 years of related experience, preferably in oncology clinical trials.
Strong knowledge of clinical research conduct including GCP, ICH guidelines, and FDA regulated studies.
Salary range: $79,200 to $143,400 annually with comprehensive benefits.
Collaborate with multidisciplinary teams, institutional faculty, industry sponsors, and regulatory agencies.