Clinical Research QA Coordinator - Audits & Compliance

University of California - Irvine Health; Orange (CA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Travel to Irvine campus

Job summary

UC Irvine Health is seeking a Quality Assurance Coordinator to perform internal QA monitoring and auditing for CFCCC studies across participating sites. You will support regulatory review, data integrity, and protocol compliance.

In this role, you will coordinate external audits, manage CAPA processes, and liaise with auditors and study teams to ensure timely, accurate documentation and regulatory adherence across the clinical research program.

Qualifications

• Strong understanding of clinical research conduct (GCP, ICH) across trials.
• Experience reviewing/verifying timely submission of clinical trial data.

Responsibilities

• Conduct and assist with internal quality assurance monitoring and auditing for CFCCC studies.
• Coordinate external audits under QA Officer guidance.
• Lead CAPA processes to ensure corrective actions are completed and effective.
• Communicate audit dates and details with auditors and CFCCC study teams.
• Ensure documentation readiness across sites, regulatory checks, and data integrity.

Skills

GCP/ICH knowledge

Clinical trial data review

Interpersonal skills

Communication skills

Organizational skills

Team collaboration

Confidentiality

Transportation to off-site locations

MS Office proficiency

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

UC Irvine Health is seeking a Quality Assurance Coordinator to perform internal QA monitoring and auditing for CFCCC studies across participating sites. You will support regulatory review, data integrity, and protocol compliance.

In this role, you will coordinate external audits, manage CAPA processes, and liaise with auditors and study teams to ensure timely, accurate documentation and regulatory adherence across the clinical research program.