Fiscal Manager & Trial Study Start-Up Manager - Clinical Research Division | GenomeWeb

Fiscal Manager & Trial Study Start-Up Manager - Clinical Research Division

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 Fiscal Manager and Trial Study Start-up is responsible for providing operational oversight of the administrative implementation and financial management of clinical research studies within the Clinical Research Division at Fred Hutchinson Cancer Research Center, an NCI designated cancer center.

This leader will provide clinical, administrative, and financial direction within clinical research while mentoring and developing program staff in CRD. It is critical that this individual have at least 5 years of experience with research budget management. This individual will also have the skills and understanding of how a cancer consortium functions as an investigative site of practice as well as the business acumen to financially support and enhance the lifecycle of clinical research operations. Assures accuracy of study budgets and contracts and reconciles study expenditures throughout protocol implementation.

This individual will partner with Principal Investigators and Administration to develop a collaborative work environment with his/her research managers and staff. This includes understanding the details of clinical research start-up, implementation, budgeting, essential documents, trial conduct, fiscal management, and project close-out. Special skills and knowledge are applied in budgeting and managing complex clinical research projects.

- Manage complex fiscal and administrative implementation activities, and ongoing management of clinical studies, ensuring all projects are completed according to project/study timelines.
- Train and guide program administrators who build budgets and billing plans for clinical-based studies according to industry, foundation and grant guidelines.
- Serve as project/study/Clinical Research Division liaison, representing the project/study/Division to other Center departments, funding sources, affiliated individuals or institutions, and outside organizations.
- Work with the Clinical Research Support Office to establish clinical trial budget set-up, management and close-out processes for the Division and Center.
- Create and maintain clinical trial budgets, enrollment, and study activity tracking tools.
- Negotiate research budgets with partner institutions and industry sponsors.
- Liaise with clinical sites of practice to obtain study pricing and plan study logistics within the clinical setting; attend study implementation meetings as necessary.
- Monitor and reconcile project/study budget, ensuring that all financial allocations and expenditures are in accordance with billing plans, budgets and grant/contract guidelines and regulations.
- Ensure program administrators are appropriately tracking clinical research study activity including accrual milestones, invoices and personnel time.
- Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, IRB, grant/contract and Center specifications.
- Track study data and compile data reports.
- Assist in tracking study staff time and effort on clinic research studies.
- Carry-out complex research assignments in support of project/study, requiring related education and/or experience.
- May coordinate the work of project/study staff.
- Produce special and recurring reports.

Required:
- BA/BS degree in related field is required.
- Minimum of 5 years of direct experience in research budget management , preferably with industry-sponsored clinical trials .
- Experience in the design and execution of complex clinical studies/programs. The candidate must have solid understanding of clinical research trial development, implementation and conduct processes, specifically significant experience with responsible roles in the conduct and management of Phase 1 - 3 clinical trials.
- Demonstrated understanding of research budget management.
- The candidate should have significant experience with responsible roles in the conduct and management of Phase 1 - 3 clinical trials.
- Must have a good working knowledge of medical terminology and excellent knowledge of applicable regulations and guidelines.
- Advanced skills in Excel, Word, Adobe Acrobat Pro and Outlook.

Preferred:
- Master's degree preferred.
- Clinical research certifications also preferred.

Key Skills and Abilities:
- Effective and professional written and verbal communication skills are required.
- Should be highly organized, detail oriented, a self-starter and be comfortable with broad responsibilities in a large, complex multi-institute environment.
- Demonstrated ability to work successfully as both an individual contributor and part of a diverse team.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2337004-2647-6621

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