Quality Assurance Coordinator - Hybrid

About the role

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.

Responsibilities

• Conducts systematic clinical data monitoring and auditing which includes informed consent process and documentation verification, subject eligibility confirmation, electronic medical record review, review for documentation and reporting of serious adverse events/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.
• Leads and coordinates external audits under the direction of the Quality Assurance Officer.
• Communicates with the auditor, all applicable CFCCC research staff and institutional research oversight offices/committees (e.g. UCI IRB and UCI Health Compliance & Privacy Office) regarding audit dates and pertinent details.
• Works with study teams to ensure all relevant and requested documents are adequately prepared and presented.
• Serves as a point of contact for external audits and facilitates communication between all parties.
• Oversight of the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness as required.

Requirements

• Strong understanding of clinical research conduct (GCP, ICH guidelines) with knowledge of both current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials.
• Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings.
• Strong interpersonal skills and ability to interface with institutional faculty, administrators and other staff, industry sponsors and regulatory agencies.
• Flexible, multitasking, and comfortable in a deadline-driven environment.
• High-level communication skills including difficult conversations and presentations.
• Strong organizational and planning skills, attention to detail, and ability to solve complex problems as well as handle multiple projects/problems simultaneously.
• Collegiality and cooperation with interdisciplinary team.
• Interacts with persons of various social, cultural, economic and educational backgrounds.
• High level of integrity and honesty in maintaining confidentiality.
• Access to transportation to off-site research locations.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).

Preferred

• Society of Clinical Research Administrators (SoCRA) or Association of Clinical Research Professions (ACRP) certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research).
• Experience with monitoring or auditing FDA regulated studies for highly complex clinical trials.
• Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Clinical Trial Professional certification from a professional society.