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Clinical Research Manager

Company: University of California- Irvine
Location: Orange
Posted on: April 16, 2019

Job Description:

The Clinical Research Manager (CRM) reports to, and is directly responsible to, the Assistant Director, Clinical Trials Unit for all clinical research matters fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise.
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 -175 members engaged in research and offers multidisciplinary cancer care to its patients.
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 incumbent is also responsible for maintaining communication with all elements of a multi-level 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 supervises the day-to day management of a team of Clinical Research Coordinators (CRCs), Assistant Clinical Research Coordinators and Assistant Research Data Coordinators overseeing and coordinating 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 CRC compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits.
The CRM is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team. The CRM is directly responsible for the management of staff. 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.
Additionally, the incumbent is responsible for leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc. ) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives through routine audit reviews of the team*s portfolio.

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.

Salary: Monthly $4,968.58 - $6,755.83
Total Hours: 8-5, M-F
2 Career Positions.
Required travel to off-site satellite clinics and Irvine Campus.
Required after-hours and weekend work hours on deadline-driven projects.
Possible travel to affiliate clinic sites on federal cooperative group studies.
Final candidate subject to background check.
As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.

Keywords: University of California- Irvine, Orange , Clinical Research Manager, Healthcare , Orange, California

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