Clinical Research Manager

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 the anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It is 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 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, the Center supports hundreds of clinicians and researchers dedicated to innovating, accelerating, growing and inspiring new ways to address and treat disease.

Our devoted team of nationally regarded physicians, nurses, researchers, 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.

Under the general direction of the Assistant Director of Clinical Research Operations in the School of Medicine – Center for Clinical Research, the Clinical Research Manager (CRM) is responsible for all clinical research matters in fulfilling the mission of the Center under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The CRM provides high‑level analytical support for strategic initiatives for the regulatory operations and implementation of the Center’s clinical trial portfolio.

The CRM serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The CRM is also responsible for maintaining communication with all elements of a multi‑level research network and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The CRM supervises the day‑to‑day management of a team of Clinical Research Coordinators, Assistant Clinical Research Coordinators and Research Data Coordinators overseeing a large portfolio of complex oncology clinical studies. The CRM is directly responsible for ensuring the team’s adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits.

In addition, the incumbent leads ongoing training and education of the Coordinators, manages pre‑study site selection visits (PSSVs), liaises with medical service units (Investigational Drug Service, Pathology, Radiology, etc.) for trial conduct, and manages quality assurance and quality improvement goals through routine audit reviews of the team’s portfolio.

Required:

• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast‑paced and dynamic work environment. Adaptability to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration; training others, particularly in research.
• Critical thinking skills to evaluate issues and identify…