• CRS Program Operations Director

    Job ID
    13025
    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 Clinical Research Support Director of Clinical Operations is responsible for direct oversight of programs that support start-up, scientific review, and NCI data reporting for Cancer Consortium clinical research. The incumbent leads the relevant operational design and oversight of the Clinical Trial Management System (CTMS). The incumbent defines and report metrics to study teams and Consortium administration working towards system improvements within the incumbent’s team, as well as throughout the Consortium.


    The incumbent manages multi-disciplinary teams. They will attract, develop, and retain strong teams; contribute to short and long-term organizational planning and strategy as a member of the management team to strategize growth and resource utilization. The position reports directly to the Director of CRS.

    Responsibilities

    Oversee central study startup program:

    • Manage, oversee, and scale trial startup portfolio to ensure coordinated study reviews, budget and contract negotiations, and compliant source documentation within the Consortium
    • Work across CRS teams and other partner organization functions needed to support study startup
    • Gather and report study startup metrics and status on a regular basis
    • Identify study startup process issues and resource needs across the Consortium; propose and implement solutions
    • Create tools to manage the study startup process
    • Represent Consortium start-up processes and central support to leadership, faculty, study teams, and external organizations
    • Lead efforts to improve start-up processes across the Consortium

    Direct the startup protocol review and data reporting functions:

    • Oversee committee management for the Scientific Review Committees (SRC); ensure that the Consortium meets NCI’s requirements for the SRC including start-up, trial prioritization and trial accrual rates.
    • Propose and manage Consortium policies to ensure the Consortium meets SRC and data reporting requirements

    Serve as Consortium and Fred Hutch institutional lead on the CTMS workflow development:

    • Provide support and leadership to CTMS implementation and management
    • Ensure CTMS operations are in alignment with the business needs of the Consortium

    Leadership:

    • Represent Clinical Research Support services to study teams, faculty, leadership, and peer institutions
    • Identify gaps in Consortium research support; implement new programs and services to address operational gaps
    • Represent CRS at Cancer Consortium meetings, committees and performance improvement initiatives
    • Identify, champion, and implement process improvement opportunities to Fred Hutch and Consortium executive leadership, by providing sufficient context, data, as well as recommended solutions and resources.

    Qualifications

    Experience and Abilities

    • 5-10 years starting and managing clinical trials operations, preferably oncology
    • Managing multi-disciplinary teams
    • Communicating with all levels of a research organization
    • Working across different academic institutions to facilitate research projects
    • Working with multi-disciplinary teams
    • Forecasting and meeting deadlines
    • Coaching study teams
    • Strong understanding of NCI mandates for data reporting and infrastructure
    • Using judgment and effective decision making skills with competing interests and priorities


    Knowledge and Skills

    • Bachelor’s Degree
    • Master’s degree healthcare related field preferred
    • Clinical research related certification preferred
    • Familiarity with process improvement principles
    • Familiarity with project management tools and techniques
    • Strong verbal and written communication skills
    • Knowledge of the regulatory environment surrounding clinical trials

    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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