• Clinical Trial 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.


    Job Summary


    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 industry-sponsored clinical trials and creating start-up plans including review requirements and timelines. This position will work closely with internal and external 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, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met. This position will facilitate and support centralized study start-up standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of the research process for industry-sponsored clinical trials, knowledge of start-up requirements, clinic implementation, and financial resources required to conduct clinical research.


    • Report start-up progress to industry sponsors, Investigators and study teams weekly to ensure transparency throughout the start-up process
    • Generate financial tools that enable study teams to maximize post award management and cost recoveryProject manage the study start-up timeline and operations (including budget development, negotiations and clinic implementation) in continuity centralized study start-up best practices with the goal of standardization and efficiency in support of larger CRS strategic initiatives
    • Review and assess new clinical trial documents to identify operational and resource requirements
    • Identify research costs, develop comprehensive budgets and maximize negotiation of industry sponsored clinical trials that support protocol implementation and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.)
    • Prepare, submit, and manage internal financial and clinic implementation processes on behalf of the study team
    • Initiate and facilitatemeetings with industry sponsors and study teams (i.e., development and review of projected start-up timelines, milestones and comprehensive integration of protocol requirements for study implementation)
    • Maintain source documentation and records throughout the start-up process for continuity with internal file structure, naming conventions, start-up best practices and transparency at the time of study hand-off
    • Monitor and maintain centralized internal logs and trackers to maximize transparency and efficiency among CRS Start-Up Team members
    • Work closely with Start-Up Operations Manager, CRS Start-Up Team members, Consortium members and study teams to support comprehensive study start-up plan, goals and deadlines
    • Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure all protocol requirements can be met upon implementation


    Minimum qualifications

    • Minimum 3-5 years’ experience in industry-sponsored clinical trials, preferably oncology trials
    • Bachelor’s Degree
    • Preparing and/or reviewing study start-up documents
    • Working across different academic institutions to facilitate research projects
    • Working with multi-disciplinary teams
    • Experience preparing, negotiating and/or managing industry-sponsor clinical trials budgets
    • Forecasting and meeting deadlines
    • Communicating with all levels of a research organization

    Preferred qualifications

    • Basic knowledge of clinical trial budgets
    • 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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