Quality Assurance Coordinator- Hybrid Job Listing at University of California in Irvine, CA (Job ID 63147)

Description

Required Qualifications
Job Opening ID: 63147 Reports To: Quality Assurance Officer Working Title: QUALITY ASSURANCE COORDINATOR - HYBRID Department: Cancer Center Bargaining Unit: 99 FLSA: Non-Exempt Payroll Job Code: 006229 Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5, M-F Employee Class: Staff

 

Position Summary:
  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 high-risk 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.

 

Total Compensation:

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.

 

$29.26 - $51.29 (Hourly Rate)
  Department Website:

https://cancer.ucihealth.org/

Required:
 

• 3-5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience
• 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.

 

Preferred:   Clinical Trial Professional certification from a professional society 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)
    Special Conditions Required:   Travel to Irvine campus and satellite work sites as needed
 

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
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

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, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination 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 (949) 824-0500 or eec@uci.edu

 Apply on company website