• Regulatory Affairs Associate

    Job ID
    10947
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    The Senior  Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. The position will prepare IRB documents and other study-related tools for the start-up and management of clinical trials including the IRB application, consent form, study synopsis, annual renewals, modifications, eligibility checklists, and study management tools. The incumbent will report to the CRS Regulatory Operations Manager.

    Responsibilities

    • Prepares IRB documents for local and central IRBs including the IRB application, consent form, study synopsis, annual renewals and modifications.
    • Creates and maintains study management templates for CRS to disseminate to study teams such as eligibility checklists, study calendars and patient tracking tools
    • Writes local consent forms from industry templates as well as from investigator initiated protocols
    • Liaises with investigator and study teams to ensure accuracy of documentation
    • Extracts data from Institutional databases to report study accrual data

    Qualifications

    Experience and Abilities

    • 5+ years working in clinical research environment
    • Reviewing IRB documentation and research protocols
    • Writing technical documents

     

     

    Knowledge and Skills

    • Bachelor’s Degree
    • Clinical research related certification preferred
    • Strong verbal and written communication skills
    • Excellent time management skills
    • Advanced knowledge of MS Word and Acrobat

    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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