Senior Quality Assurance Coordinator

University of California, Irvine•Orange, CA

17h

About The Position

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 www.uci.edu. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose mission is to promote and enhance cancer-relevant research, education, and patient care at UC Irvine. The CFCCC conducts interdisciplinary and transdisciplinary research into the causes, prevention, therapy, and survival of cancer, trains the next generation of cancer Investigators and care providers, serves as a community and regional resource for state-of-the-art information and expertise on cancer, and delivers the highest-quality multidisciplinary care to cancer patients and their families within our catchment area. To facilitate this, the CFCCC provides research resources to its ~280 cross-institutional members engaged in this research. 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 Senior Quality Assurance Coordinator role lies within the Quality Assurance Unit, which is responsible for quality assurance activities, including training and education, in order to ensure trial participant safety and data integrity oversight. Your Role on the Team The Senior Quality Assurance Coordinator conducts internal quality assurance audit and monitoring 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. The Senior Quality Assurance Coordinator leads and coordinates audits for all high-risk trial-related activities for investigator-initiated, industry-sponsored and National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN) clinical research trials to ensure compliance with the protocol plan, internal policies, human subject federal regulations, standard operating procedures (SOPs), GCP, University policies and procedures and all other relevant regulations.

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
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.
Experience with monitoring or auditing FDA regulated studies for highly complex clinical trials
Ability to sit and work at a computer for several hours per day.
Bachelor's degree in related area and / or equivalent experience / training
3-5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience
Experience in oncology clinical trials.

Nice To Haves

Knowledge of pertinent policies, procedures, regulations and requirements of UC, State, Federal, and other agencies pertaining to research and administrative management.
Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored)
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) or equivalent
Relevant compliance certification (if applicable) preferred.

Responsibilities

conducts internal quality assurance audit and monitoring 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.
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.
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.
work with study teams to ensure all relevant and requested documents are adequately prepared and present.
serves as a point of contact for external audits and will facilitate communication between all parties.
oversee the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness as required.
leads and coordinates audits for all high-risk trial-related activities for investigator-initiated, industry-sponsored and National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN) clinical research trials to ensure compliance with the protocol plan, internal policies, human subject federal regulations, standard operating procedures (SOPs), GCP, University policies and procedures and all other relevant regulations.

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