• HVTN Regulatory Project Coordinator

    Job ID
    11937
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Project Management
  • 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 HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines and other prevention methodologies to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines and antibody products for safety and immunogenicity to testing for efficacy.

     

    The Project Coordinator position will support the HVTN’s Leadership Operations Center (LOC) for the Regulatory Affairs and other groups as needed. The incumbent works under the direction of the Director of Regulatory Affairs. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying-out moderately complex clinical trials operations and research assignments.

    Responsibilities

    • Proactively monitor sites’ target dates for regulatory and ethics body submissions and approvals and completion of Protocol Activation items in order to prevent delays in study start at sites
    • Trouble-shoot potential delays in Protocol Activation items by working with sites and other members of the LOC
    • Support the Director of Regulatory Affairs in ongoing Lean and continuous improvement activities for the LOC
    • Serve as HVTN’s Financial Disclosure Coordinator: participate in refining cross-Network process; prepare data for annual solicitation; compile and organize results of solicitation for Regulatory Ethics Conflict of Interest (RECOI) subcommittee review; provide administrative support to RECOI
    • Coordinate translation and distribution of safety-related documents to sites
    • Coordinate the regulatory aspects of specimen management, including tracking specimen destruction triggers and completing tasks associated with ancillary/exploratory studies
    • Prepare and distribute documentation to sites and NIH’s Office of Science Policy to ensure compliance with NIH’s Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
    • Work with protocol team leadership at DAIDS to register Applicable Clinical Trials to NIH’s clinicaltrials.gov website
    • Compile Clinical Study Reports and facilitate applicable internal reviews
    • Provide administrative support for submissions to the Fred Hutch IRB, including assembling submission packages and electronically filing submissions and approvals
    • Provide administrative support for the sign-off of site Material Transfer Agreements (MTAs)
    • Work with other LOC Project Coordinators/Managers to improve cross-unit processes/systems, execute and implement special projects
    • Perform other tasks as assigned

    Qualifications

    • BA/BS in related field required, other relevant work experience may substitute
    • Experience in Lean methodologies highly desired
    • Position requires a high level of attention to detail and organization
    • Excellent written and verbal communication skills
    • Good interpersonal skills, and an ability to maintain confidentiality are essential
    • Must have demonstrated ability to work independently and take initiative in a dynamic environment
    • High level knowledge of Microsoft applications, specifically Word, Excel, PowerPoint, and Outlook are required, knowledge of SharePoint is preferred

    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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