Clinical Trials Project Manager

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. 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 position will be responsible for the fiscal and project managment of clinical research studies conducted within the Immunotherapy Integrated Research Center (IIRC). Prepares, administers, and maintains study budgets in accordance with the study protocol and works with the fiscal manager to coordinate all financial activities associated with clinical trial protocols. Assures accuracy of study budgets and contracts and reconciles study expenditures throughout protocol lifecycle. Tracks progress of clinical trials through the study startup process.

Interacts with IIRC Director and staff, patients, physicians, and other clinical providers and support staff within and outside of the FHCRC/SCCA/UW system including the SCCA Immunotherapy Transplant Service. Establishes and maintains professional relationship with study sponsors and regulatory agencies.

Project Management: Budget
- Interface with IIRC and Program in Immunology faculty, CRS, and Office of the General Counsel to develop, negotiate, and manage highly complex clinical trial budgets, working directly with Program faculty and staff to anticipate new study support needs and budget accordingly and ensure budgets are amended to reflect revisions to study protocols
- Ensure study invoices are submitted, and sponsor payments are received in a timely manner.
- Work closely with Program's Fiscal Analyst/Manager to forecast and track study costs.
- Coordinate clinical trial study audit and close-out
- Provide ongoing cost analysis for studies to ensure clinical trials are adequately funded; provide budget information to Alliance Management for negotiation of budget revisions with sponsors.

Project Management: Clinical Trials Startup and Operations
- Track all IIRC and Program in Immunology studies in startup, developing plans with parallel workstreams and clear timelines, communicating between stakeholders, and holding accountable the team members whose input is required.
- Work with Center and Consortium departments to continuously identify operational issues and areas of improvement to ensure optimum conduct of clinical research studies within the IIRC and Consortium.

- BA/BS and at least 3 years managing Phase I-III clinical trials. Master's degree preferred.
- Must have previous experience developing complex, multi-phase clinical trial budgets; negotiating study budgets and revisions and knowledge of medical terminology
- Experience with study close-out and successful audit preparation.
- Strong verbal and written communication skills required
- Strong computer skills, including proficiency in Excel and Word, and experience working with databases required

- Master's degree preferred.
- Clinical research related certification preferred.
- Demonstrated familiarity with process improvement principles.
- Demonstrated familiarity with project management tools and techniques.

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