• Protocol/Operations Coordinator II

    Job ID
    Regular Full-Time
    Fred Hutchinson Cancer Research Center
    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.


    This position will provide and manage support for clinical trial start-up in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new clinical trials and creating start-up plans including review requirements and timelines. The position will work closely with regulatory and fiscal specialists to manage start-up tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams to ensure implementation needs are met. This position will develop tools and best practices for study start-up. This position requires understanding the research process and resources required to conduct clinic research.


    • Review and assess new clinical trials to identify operational, regulatory and resource requirements
    • Work closely with study teams to create start-up plan and implement resources to assist with study start-up tasks including budgeting and regulatory
    • Identify and sometimes generate tools and/or templates for study teams to use post implementation based on specific study requirements identified during the start-up process
    • Oversee the study start up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevent regulatory submissions
    • Work with clinic partners to ensure all protocol requirements can be met upon implementation
    • Develop and maintain procedures for the department and Consortium with the goal of standardization, increased efficiency and ensuring compliance
    • Maintain direct communication with faculty members, clinic departments, funding sponsors, and research collaborators in support of the overall research plan; report start-up progress to PIs and study staff ensuring transparency during the process and identifying any issues
    • Collaborate with Consortium members, clinic partners and leadership to establish study start-up best practices
    • Help determine clinical trial budget standards based on data from the Consortium
    • Stay current with budgeting trends in clinical research; makes recommendations to leadership
    • Participate in study implementation related process improvement efforts on behalf of the Consortium including implementation of technology solutions
    • Develop tools to assist study teams with start-up process


    Minimum qualifications

    • Minimum 5 years experience in clinical trials, preferably oncology trials
    • Bachelor’s Degree
    • Preparing and/or reviewing study startup documents (i.e., IRB applications)
    • Working across different academic institutions to facilitate research projects
    • Working with multi-disciplinary teams
    • Preparing, negotiating and managing industry sponsor clinical trials budgets
    • Forecasting and meeting deadlines
    • Communicating with all levels of a research organization

    Preferred qualifications

    • Clinical research related certification preferred
    • Familiarity with project management tools and techniques
    • Strong verbal and written communication skills
    • Knowledge of applicable local, state and federal regulations and guidelines

    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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