Sr. Clinical Trial Operations/Project Manager

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Clinical Research Division of the Fred Hutchinson Cancer Research Center is seeking an experienced administrator with a clinical trials background to help coordinate the clinical research activities of the Division (75% effort) and to perform special projects specified by the CRD Director (25% effort). This position will report administratively to the CRD Administrator, but will report directly to the CRD Director for special projects. It is critical that this individual work closely with the Director of Clinical Research Support (CRS) for clinical research issues and that this position ensures integration of CRD clinical trials activities with those of the centralized Clinical Research Support group to ensure that CRD research activities are consistent and compliant with those of the Fred Hutchinson and University of Washington Cancer Consortium.

- Determination of staffing needs. This position will work with the Division and HR to create positions and recruit clinical trial personnel to serve as divisional resources for the CRD administrative office and for research groups within CRD while maintaining consistency in titles and salary levels across the Division. This administrator will assure that CRD faculty will be prominently involved in staff recruitment, interviewing, and hiring decisions, and that they contribute to annual performance evaluations.
- Facilitation of study "start-up" for new trials. The successful candidate for this position will work closely with CRS to improve the efficiency of the start-up process and accelerate opening of new CRD trials.
- Prioritization of study protocols and allocation of staffing.
- Review and prioritization of the workloads of divisional regulatory staff, budget staff, clinical research coordinators, and clinical research nurses.
- Provision of day-to-day oversight of the CRD clinical research enterprise and development of performance metrics for clinical research teams including research managers and their staff.
- Allocation of CRD staff support to faculty members, assisted by input from CRD Research Group Clinical Research Managers.
- Ensure consistent use of institutional SOPs, development of Division-specific SOPs and study-specific SOPs for the conduct of clinical research within the CRD.
- The Clinical Trial Operations Administrator will work with the CRS Training Program Manager to ensure training of CRD staff and core competencies are commensurate with role.
- Development of corrective action plans for clinical trial deficiencies and delinquencies to ensure compliance with institutional, regional, and national policies, in collaboration with the CRS Quality and Compliance. Work with CRD clinical research managers to implement corrective actions.
- Maintain documentation of staffing information for CRD clinical trials and ensure study contact information is current in central institutional databases.
- Review of annual performance evaluations for clinical trial managers and their staff submitted by CRD faculty members. The Clinical Trial Operations Administrator will personally perform annual performance evaluations for clinical research staff who do not work directly for a single faculty member, integrating input from all faculty members who work with the staff member. This administrator will also develop a policy tying salary increases to the annual performance evaluations.
- Development of an exit plan to reassign studies and staff effort when a PI leaves.
- Responsibility for maintenance of information on all clinical trial grants and contracts for CRD faculty, while coordinating with Center-wide and Consortium-wide databases and systems
- Identification of other services and resources needed to support CRD clinical trials.
- Execution of "Special Projects" assigned directly by the CRD Director. These projects may involve clinical research issues, interactions with the IACUC committee, database and systems support, or issues dealing with faculty recruitment and professional advancement.
- Work closely with Division fiscal managers to strategize use of study team resources and ensure clinical trial personnel time and research billing is appropriate.

- BA/BS degree in related field is required. A Master's degree is highly desirable.
- A minimum of 5 years of direct experience in clinical trials management and administration. Industry-sponsored and investigator-initiated clinical trials experience is highly desired.
- A sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects is required.
- A strong knowledge of clinical trials with excellent management and interpersonal skills.
- Clear and concise communication skills and an ability to achieve consensus across stakeholders. This will be essential to drive organizational change.
- Excellent relationship skills to build relationships with faculty members and and professional staff.
- An approachable leadership style with strong mentoring capabilities and a strong emphasis on collaboration.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2343307-2647-621

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