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 Committee Operations Manager will be responsible for overseeing the Cancer Consortiums clinical trial oversight committees, including the Scientific Review Committees (SRCs) and the central Data and Safety Monitoring Committee (DSMC) and individual study Data and Safety Monitoring Boards (DSMBs). The position is responsible for ensuring that these functions meet all federal and institutional requirements and that the operations are supported by sufficient documentation and staffing resources. The position will work closely with Consortium faculty and leadership to provide performance metrics and to report overall committee performance. This position requires understanding the clinical research process and the NCIs cancer center requirements for scientific review. The position reports directly to the Sr. Operations Manager and supervises 1-2 Committee Coordinators.
Manage the Consortiums SRCs and DSMC, ensuring that the committees meet all NCI and Consortium review requirements.
Ensure committees have:
Appropriate faculty membership and Chair oversight
New committee membership training
Sufficient meeting and review documentation
Review times that meet defined turn-around-time standards
Liaise with the Consortiums Institutional Review Office to ensure appropriate committee communication between the SRC and IRB.
In collaboration with committee chairs, manage membership rosters
Collate and present quarterly SRC metrics including review timelines, approval rates, low trial accrual review closures; recommend operational changes to correct any issues
Manage the Consortium low-accrual policy and propose any changes to ensure accruals meet NCI requirements
Develop and maintain standard operating procedures, reviewer forms, and meeting templates for committee management
Define, track and generate regular performance metrics for committees
Plan and manage resources to support all applicable committee functions; plan for increased DSMB management
Liaise with Clinical Trial Management System (CTMS) Program Office to ensure required data is captured and QCd to meet committee management and reporting needs
Identify and implement technical solutions to support efficient committee operations; define system requirements and create user support documentation
Experience and Abilities
3-5 years managing clinical research operations, preferably in oncology
Managing faculty committees
Working with multi-disciplinary teams
Managing research data sets
Communicating with all levels of a research organization
Knowledge and Skills
Clinical research related certification preferred
Strong verbal and written communication skills
Knowledge of applicable local, state and federal regulations and guidelines
Understanding of NCI Cancer Center clinical trial infrastructure
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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.