• Committee Operations Manager

    Job ID
    14368
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    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 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 Committee Operations Manager will be responsible for overseeing the Cancer Consortium’s 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 NCI’s cancer center requirements for scientific review. The position reports directly to the Sr. Operations Manager and supervises 1-2 Committee Coordinators.

    Responsibilities

    • Manage the Consortium’s 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 Consortium’s 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

    Qualifications

    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

    • Bachelor’s Degree
    • 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

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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