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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The NCTN Clinical Trials Manager is responsible for the management of the NCTN clinical research coordinator team in Clinical Research Support (CRS). CRS is the central clinical trials office for the Fred Hutch/University of Washington Cancer Consortium. This position is responsible for developing, implementing, and maintaining procedures to ensure sufficient oversight of all NCI cooperative group studies managed by the Consortium and Consortium affiliate sites. Oversees the day-to-day operations of all NCTN clinical trials for the Cancer Consortium. The position manages a team of 6 protocol specialists (clinical research coordinators). The NCTN team works closely with disease groups study teams across the Consortium to enroll and manage subjects through the trial lifecycle.
Directly supervisesteamof protocol specialists, data coordinators, clinical research assistants, and contracted services for long-term follow-up tracking.
Ensures disease group study teams and CRS study staff adhere to national cooperative group study requirements, Consortium policies, and procedures.
Manages vendor contracts for long-term follow-up data support services; identifies opportunities to streamline operations by contracting services.
Strategizes and implements teamgrowth and viability; assess and plan ongoing resource needs.
Works closely with Consortium faculty, study teams, and clinic to ensure efficient and compliant conduct of NCTN trials.
Performs ongoing assessment of Program effectiveness, including assessment of NCTN models division of responsibilities between CRS team and disease groups study teams.
Analyzes and reports out NCTN clinical trial monthly metrics to CRS leadership, NCTN team and other CRS stakeholders.
Collaborates with NCTN Program Manager, Regulatory and Financial teams to ensure successful implementation of new NCTN trials.
Collaborates with the NCTN Program Manager and CRS leadership to assist with the strategic planning of the team according to NCI and institutional priorities.
Forms and maintains strong collaborations with Consortium partners, including clinic partners and Consortium disease groups.
Recommends and communicates policy, procedure and practice changes relating to NCTN trials in the Consortium; represents CRSclinical trial best practices and NCTN trials throughout the Consortium.
Experience and Abilities
5-10 years coordinating oncology clinical research;NCI cooperative group trial experience preferred
Experience in management or team leadership/supervisory experience; managing large clinical research teams preferred
Working across different academic institutions to facilitate research projects
Working with multi-disciplinary teams
Coaching and supporting study teams
Communicating with all levels of a research organization
Knowledge and Skills:
Bachelors Degree required
Masters degree in a healthcare related field preferred
Clinical research related certification strongly preferred
Excellent interpersonal skills with the ability to build strong relationships across multiple organizations
Strong verbal and written communication skills
Familiarity with process improvement and project management principles
Understanding of clinical trial regulatory and budgeting
Advanced knowledge of FDA research policies, other applicable federal regulations and GCP guidelines
Expertise in various electronic data capturing systems (EDC) and clinical trial management systems/databases
Advanced knowledge of standard office software packages (Word, Excel, PowerPoint, Project, Acrobat, Visio, etc.)
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.