• Regulatory Affairs Project Manager, HVTN

    Job ID
    12457
    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 Regulatory Affairs Project Manager position will support the HVTN’s Leadership Operations Center (LOC) and will work in close collaboration with Fred Hutch’s Office of Business Development & Strategy (BD&S) and Office of General Counsel (OGC). The incumbent works under the direction of the HVTN Director of Regulatory Affairs. Special skills and knowledge are applied in drafting, reviewing, and negotiating legal agreements and in carrying-out moderately complex regulatory aspects of clinical trials operations and research assignments.

    Responsibilities

    Perform some or all of the following responsibilities:

    • Proactively monitor the need for legal agreements to support the implementation of upcoming HVTN studies and subsequently manage workflow to ensure timely execution of agreements
    • Follow work practice guidelines for putting agreements in place, while using critical thinking skills to make decisions that limit risk
    • Draft Material Transfer Agreements (MTAs) based on specimen types and volumes defined in the clinical trial protocol to allow receipt of specimens from sites in Africa
    • Work with stakeholders in BD&S and OGC, as well as sites and external labs to review and negotiate MTAs
    • Work with OGC to coordinate the negotiation of Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and other relevant legal agreements with study sponsors and product developers
    • Work with BD&S and OGC colleagues, as well as colleagues in the LOC, Statistical and Data Management Center (SDMC), and/or Laboratory Center (LC) to coordinate the negotiation of other legal agreements, as necessary
    • Assure that agreement terms and provisions are in compliance with HVTN policies and procedures
    • Advise LOC, SDMC, and LC colleagues on the need to operationalize new/unique requirements in the legal agreements
    • Determine potential need for agreement amendments and coordinate amendment execution with stakeholders
    • Track sites’ Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring
    • Work with sites to trouble-shoot the resolution of any lapses in continuing review
    • Proactively track 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
    • Trouble-shoot potential delays in Protocol Activation items by working with sites and other members of the LOC, SDMC, and LC
    • Perform other tasks as assigned

    Qualifications

    • BA/BS required, plus 2 to 4 years technology transfer, legal, or other related experience. MA/MS is preferred.
    • Sharp critical thinking skills
    • High level of attention to detail and organization
    • Ability to read and understand a clinical trial protocol
    • Excellent written and verbal communication skills
    • Good interpersonal skills, and an ability to maintain confidentiality are essential
    • 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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