• Regulatory Coordinator

    Job ID
    11526
    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 Immunology and Vaccine Development (IVD) Program is a large and diverse program within the Vaccine & Infectious Disease Division. The program supports the research of more than 10 Principal Investigators (PIs), more than 75 active grants and a research staff of more than 160.

    Responsibilities

    The Regulatory Coordinator will be responsible for coordinating the IRB (Institutional Review Board) and Institutional Animal Care and Use Committee (IACUC) files working under the supervision of the Regulatory Affairs Manager.

    • Write and prepare IRB submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc.
    • Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, IACUC, and lab safety policies. Along with the PI, prepare and track all lab activity documents including IACUC approvals, EMUAs, IBC approvals, IRB approvals, DEA licenses, EH&S amendments including chemical inventory, lab safety inspections & compliance, etc.
    • Coordinate site registration activities with sponsors.
    • Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
    • Assist in the coordination of project activities to ensure they follow timelines.
    • Assist in the development of research materials.
    • Perform information searches related to studies and projects.
    • Responsible for the IRB paperwork included in grant submissions, study results, etc. to ensure all guidelines are followed.
    • Provide clear and concise professional communication in response to reviewing bodies and regulatory agencies.
    • Use judgment to interpret and apply federal and local regulations regarding clinical research.
    • Perform other responsibilities as assigned.

    Qualifications

    • Bachelor’s degree.
    • Minimum of two years’ experience in a related field.
    • Previous experience in Human Subjects desired and successful completion of Human Subjects Training will be required.
    • Strong computer skills with proficiency in Microsoft Word, Excel, Access, Outlook, and PowerPoint required.
    • Skills in Microsoft Project recommended.
    • Must be highly organized and able to manage multiple tasks and deadlines.
    • Able to work with minimal supervision and within a team environment.
    • Excellent writing and communication skills.

    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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