• NCTN Clinical Trials Manager

    Job ID
    14069
    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 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 group’s study teams across the Consortium to enroll and manage subjects through the trial lifecycle.

    Responsibilities

    • Directly supervises team of 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 team growth 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 model’s division of responsibilities between CRS team and disease group’s 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 CRS clinical trial best practices and NCTN trials throughout the Consortium.

    Qualifications

    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:

    • Bachelor’s Degree required
    • Master’s 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.)

    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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