Clinical Research Manager
Company: University of California- Irvine
Posted on: June 14, 2019
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
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
Required after-hours and weekend work hours on deadline-driven
Possible travel to affiliate clinic sites on federal cooperative
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, Executive , Orange, California
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