Clinical Research Quality Assurance and Improvement Manager - Hybrid

Company: University of California - Irvine
Location: Orange
Posted on: February 3, 2025

Job Description:

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 .
Your Role on the Team

The UCI Center for Clinical Research is driven to improve the health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic. Built as an excellent clinical research program designed to serve our patients, community, investigators and partners with a high level of efficiency, integrity and quality. With hundreds of clinicians and researchers dedicated to innovating, accelerating, growing and inspiring new ways to address and treat disease. Their expertise gives us an edge in treatments and trials related to a full spectrum of conditions. Our devoted team of nationally regarded physicians and nurses, researchers and clinicians, educators and students are all united by a single calling - to improve the lives of the people in our community and beyond. We are unique in our ability to provide the most compassionate healthcare and research because we are driven by our passion for innovation, grounded in the best medical and scientific knowledge available. Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work. The Quality Assurance and Improvement Manager (QAIM) is responsible for all clinical research auditing and regulatory compliance oversight matters in fulfilling the mission of CCR under the University of California, Irvine School of Medicine and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio. This position provides coordination and management for the administration, support, auditing, and oversight of operational research compliance functions for the Center for Clinical Research. The QAIM will establish and execute quality plans, policies and system elements related to Good Clinical Practice (GCP) activities and compliance. The QAIM works closely with CCR leadership, stakeholders, sponsors, and Principal Investigators (Pl) to address compliance challenges and issues. In this position, the incumbent will be responsible for developing and implementing a comprehensive quality assurance program in the context of clinical trials management. The QAIM builds and maintains a culture of excellence, safety, and compliance with the goal of achieving an audit-ready operation at all times. The QAIM leads and coordinates audits for all high-risk trial-related activities for investigator initiated, industry-sponsored and Federally funded research 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. The QAIM helps scale and implement clinical research training programs and will be responsible for the oversight and organization of training programs. The role includes researching and creating content and tools to streamline protocol driven activities, building a curriculum that ensures the highest quality of care through education, hands-on training, and information sharing through various mediums. The incumbent establishes and monitors quality metrics and determines how best to maintain high standards of performance.
What It Takes to be Successful

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Must possess the skill, knowledge and ability essential to the successful performance of assigned duties.
• Excellent written and verbal communication skills in English.
• Must demonstrate customer service skills appropriate to the job.
• Ability to establish and maintain effective working relationships across the Health System.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Clear and concise communicator; good verbal and written communication skills; both.
• Ability to maintain a work pace appropriate to the workload.
• Demonstrated skill to supervise, motivate, develop and effectively evaluate staff.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.Required:
  • Bachelor's degree in related area.
  • Clinical Trial Professional certification from a professional society within one year in position.Preferred:
    • Advanced degree preferred. Total CompensationIn 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 and .The expected pay range for this recruitment is $81900- $116200 (Annual).Special Conditions:
      • May require performance of work outside normal business hours. Flexible for travel between Irvine Campus and UCIMC Orange Campus
      • Must possess and maintain a valid California driver's license. Position is subject to the California DMV's "Pull Notice System" and continued employment is contingent upon proof of a satisfactory driving record.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 EnvironmentThe 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 EvaluationDetails of each policy may be reviewed by visiting the following page - Closing Statement: The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the University of California's Affirmative Action Policy please visit: . For the University of California's Anti-Discrimination Policy, please visit:. 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.
            Consideration for Work Authorization Sponsorship
            
            Must be able to provide proof of work authorization

Keywords: University of California - Irvine, Costa Mesa , Clinical Research Quality Assurance and Improvement Manager - Hybrid, Executive , Orange, California