Clinical Research QA & Audit Coordinator

UCI Health; Orange (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

UC Irvine's CFCCC seeks a Quality Assurance Coordinator to conduct internal QA monitoring and audits for multiple clinical research studies. You will manage data integrity, regulatory compliance, and audit readiness under the QA Officer's direction.

Responsibilities include coordinating external audits, documenting findings, and guiding CAPA processes; requires 3–5 years of related experience and strong MS Office skills. Travel to Irvine campus as needed.

Qualifications

• Strong understanding of clinical research conduct (GCP, ICH guidelines) with knowledge across Phase I–III trials
• Experience reviewing/verifying timely and accurate submission of clinical trial data
• Strong interpersonal skills interfacing with faculty, administrators, sponsors and regulators
• Ability to be flexible, multitask and meet deadlines in a fast-paced environment
• High-level communication skills including difficult conversations and presentations
• Strong organizational skills, attention to detail, and ability to manage multiple projects
• Team-oriented with ability to work across interdisciplinary teams
• Ability to interact with people from diverse backgrounds
• High integrity and confidentiality in handling data
• Access to transportation to off-site research locations
• Proficiency with MS Office and willingness to learn new software quickly
• 3–5 years of related work experience with a BA/BS or equivalent

Responsibilities

• Conduct internal quality assurance monitoring and auditing for CFCCC studies under the direction of the QA Officer
• Perform systematic clinical data monitoring and auditing, including informed consent review, eligibility verification, and EHR review
• Review for reporting of adverse events and drug service/pharmacy records, regulatory and protocol compliance
• Lead and coordinate external audits and communicate with auditors and CFCCC staff
• Coordinate with study teams to ensure necessary documents are prepared and available
• Serve as primary contact for external audits and facilitate communication among all parties
• Oversee CAPA processes to ensure timely completion, implementation, and effectiveness

Skills

Clinical research knowledge

Interpersonal communication

multitasking & prioritization

Technical writing

Attention to detail

Team collaboration

Integrity & confidentiality

Transportation to off-site locations

MS Office proficiency

Education

Bachelor of Arts/Bachelor of Science, or equivalent experience

SoCRA/ACRP certification or related certification (preferred)

Tools

Microsoft Office (Outlook, Word, Excel, PowerPoint)

Job description

UC Irvine's CFCCC seeks a Quality Assurance Coordinator to conduct internal QA monitoring and audits for multiple clinical research studies. You will manage data integrity, regulatory compliance, and audit readiness under the QA Officer's direction.

Responsibilities include coordinating external audits, documenting findings, and guiding CAPA processes; requires 3–5 years of related experience and strong MS Office skills. Travel to Irvine campus as needed.