Clinical Research Manager - Hybrid

Clinical Research Manager

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 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 over 200 members engaged in research and offers multidisciplinary cancer care to its patients. The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) within the CFCCC provides centralized services for protocol review and monitoring, regulatory affairs, quality assurance, clinical research business operations, and overall study and data management.

The Stern Center manages industry-sponsored, institutionally sponsored, externally peer reviewed, and national group interventional clinical trials with a clinical research portfolio of ~500 active trials.

Your Role on the Team The Clinical Research Manager (CRM) reports to an Assistant Director for the Clinical Trials Unit for all clinical research matters fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The CRM leads one (or more) disease site(s) providing direct oversight and supervision to the disease team consisting of clinical research, research data, and/or long term follow-up coordinators.

Responsible for analyzing and solving problems, interpreting policies and serve as subject matter expert in the disease area and team. Supervises staff to ensure accountability for compliance with research protocols and stewardship of the Department's resources. Serve as 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 incumbent is also responsible for maintaining communication with all elements of a multi-level and multi-disciplinary research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The CRM is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific disease team(s).

The CRM supervises the day-to day management of a team of clinical research, research data, and/or long term follow-up coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies, and is responsible for staff performance management, and programmatic workflow of projects. Supervises and delegates staff assignments to meet clinical research goals and timelines, regularly meeting with team members to ensure objectives are met while ensuring the quality and quantity of work are at appropriate standards and levels.

The CRM is directly responsible for ensuring the team's adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring CRC compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions.

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