Quality Assurance Coordinator - Hybrid

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

Founded in 1965,

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 www.uci.edu.

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.

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 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

What It Takes to be Successful

• 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 experience

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) or equivalent
• Experience with monitoring or auditing FDA regulated studies for highly complex clinical trials
• Experience with cancer-related research
• 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

Special Conditions

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

Total Rewards

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

Conditions Of Employment

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment
• Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement

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 covered by the UC Anti-Discrimination Policy.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at [phone] or [e-mail].

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization