Quality Assurance Coordinator - Hybrid

Who We Are

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing 7 billion annually to the local economy and 8 billion statewide. To learn more about UC Irvine, visit (Use the "Apply for this Job" box below)..

The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~195 members engaged in research and offers multidisciplinary cancer care to its patients. The Stern Center within the CFCCC provides centralized services for protocol review and monitoring, regulatory affairs, study management, coordination with internal and external partners on study financial terms and arrangements, and oversees accounts receivable, financial projections and reporting on clinical studies.

The Quality Assurance Unit is responsible for quality assurance activities in order to ensure trial participant safety and data integrity oversight.

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 of 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.

Additionally, the Quality Assurance Coordinator leads and coordinates external audits under the direction of the Quality Assurance Officer. The Quality Assurance Coordinator will communicate 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. The Quality Assurance Coordinator will also work with study teams to ensure all relevant and requested documents are adequately prepared and present.

The Quality Assurance Coordinator serves as a point of contact for external audits and will facilitate communication between all parties. The Quality Assurance Coordinator will also oversee the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness as required.

Required:

• 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
• Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment
• High-level communication skills including difficult conversation and presentation skills
• Strong organizational and planning skills, attention to detail, and ability to solve complex problems as well as handle multiple projects/problems simultaneously
• Ability to work collegially and cooperatively and to establish and maintain cooperative working relationships as a member of an interdisciplinary team
• Skill in interacting 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) and ability and openness to learn and become proficient with new software and web interfaces quickly.
• 3-5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience
• 3-5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent…