Quality Assurance Coordinator - Hybrid

Your Role on the Team

The Quality Assurance Coordinator conducts and assists with internal quality assurance monitoring and auditing activities for assigned clinical research studies at all participating sites under the CFCCC for the overall review of regulatory, subject management, data compliance, and Investigational Drug Service/Pharmacy research activities under the direction of the Quality Assurance Officer. Quality Assurance activities comprise systematic clinical data monitoring and auditing, including informed consent process and documentation verification, subject eligibility confirmation, electronic medical record review, review for documentation and reporting of serious adverse events or adverse events, Investigational Drug Service/pharmacy record review, deviation review and reporting, confirmation of regulatory compliance, overall protocol compliance, and compliance with all applicable university policies and federal regulations.

Additionally, the Quality Assurance Coordinator leads and coordinates external audits under the direction of the Quality Assurance Officer. The coordinator communicates with auditors, CFCCC research staff, institutional research oversight offices and committees regarding audit dates and pertinent details, works with study teams to ensure documents are prepared, serves as the point of contact for external audits, and oversees the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness.

• Strong understanding of clinical research conduct (GCP, ICH guidelines) with knowledge of current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials
• Experience reviewing or verifying the timely and accurate submission of clinical trial data and reporting findings
• Strong interpersonal skills and ability to interface with institutional faculty, administrators, sponsors and regulatory agencies
• Ability to be flexible, multitask and switch priorities in a deadline‑driven environment
• High‑level communication skills including difficult conversation and presentation abilities
• Strong organizational and planning skills, attention to detail, and aptitude for solving complex problems and managing multiple projects
• Collaborative teamwork mindset and respectful engagement with colleagues
• Skill in interacting with persons of diverse social, cultural, economic, and educational backgrounds
• Integrity and honesty with confidentiality obligations
• Access to transportation to off‑site research locations
• Working knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint) and willingness to learn new software quickly
• 3–5 years of related experience with a Bachelor of Arts/Science or equivalent

• SoCRA or ACRP certification or equivalent in regulatory, QA, or clinical research
• Experience monitoring or auditing FDA‑regulated studies for complex trials
• Experience with cancer‑related research
• Knowledge of various human subject clinical trial types (National Group, Industrial, Investigator‑authored)
• Clinical Trial Professional certification from a professional society

• Travel to the Irvine campus and satellite work sites as needed.

In addition to salary, benefits include medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks. For details on compensation practices and benefits refer to the self‑service portal.

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug‑Free Environment
• California Child Abuse and Neglect Reporting Act
• E‑Verify
• Pre‑Placement Health Evaluation

* Must disclose if subject to administrative or judicial decisions for misconduct within the last seven years.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories mandated by the UC Anti‑Discrimination Policy. The institution is committed to diversity, equity, and inclusion for all employees.

UCI provides reasonable accommodations for applicants with disabilities upon request. For information, contact Human Resources at 949‑824‑0500 or eec.

Must be able to provide proof of work authorization.