Clinical Research Manager

Apply for the Clinical Research Manager role at UC Irvine
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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. 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.

Under the general direction of the Asst. Director of Clinical Research Operations in the School of Medicine – Center for Clinical Research (CCR), the Clinical Research Manager (CRM) is responsible for all clinical research matters in fulfilling the mission of CCR 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 implementations of CCR’s clinical trial portfolio and 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 maintains 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 (CRCs), Assistant Clinical Research Coordinators and Research Data Coordinators overseeing a large portfolio of complex oncology clinical studies.

Responsibilities also include ensuring the team’s adherence to protocols, managing and distributing the clinical research workload, ensuring CRC compliance with industry and federal sponsor data entry requirements, overseeing auditing and monitoring visits, leading on‑going training and education of CRCs, managing pre‑study site selection visits (PSSVs), and coordinating quality assurance and quality improvement goals through routine audit reviews of the team’s portfolio.

Required experience:

Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters; managing multiple priorities; adapting quickly to changing priorities; overseeing staff supervision and HR administration; training others, especially in research; critical thinking; clear, concise, and effective verbal and written communication, including technical writing. The candidate must possess excellent interpersonal skills, the ability to motivate and collaborate with stakeholders at various administrative levels, maintain strict confidentiality, and establish cooperative relationships with external sponsors and colleagues.

Expertise with Microsoft Office (Word, Excel, Outlook, PowerPoint) is required. The minimum educational requirement is a bachelor’s degree in a related area with 5–7 years of experience in an academic and/or research environment. An advanced degree and SoCRA/ACRP certification are preferred. Special conditions:
Access to transportation to off‑site research locations; travel to Irvine campus and satellite work sites as needed.

• Mid‑Senior level

• Full‑time

• Research, Analyst, and Information Technology

• Higher Education

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