• Assistant Director, Institutional Review Office

    Job ID
    14716
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Executive and 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 and largest 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 Institutional Review Office (IRO) functions as the central office for managing the ethical review and approval of human or animal studies conducted at Fred Hutch, with specific responsibilities for supporting the Institutional Review Boards (IRBs) and the Institutional Animal Care and Use Committee (IACUC). The Assistant Director oversees the day-to-day operations of the IRO and its relevant committees, proactively identifying and implementing solutions to improve efficiency, effectiveness and timeliness of office processes while maintaining rigorous scientific, ethical and regulatory compliant reviews.

    Responsibilities

    • Effectively manage IRO staff supporting two functioning units within the IRO:  IRB and IACUC
    • Effectively oversee the operations of the human subject research and animal care and use programs
      • Ensure that the budget, staffing and resources for effective day-to-day operations of the IRO are adequate
      • Evaluate areas of improvement that can streamline IRO review processes, where possible to make them more effective
      • Attend all IRB and IACUC meetings
    • Collaborate with research teams and administrative departments interacting with the IRO 
      • Maintain effective relationships with key departments within Fred Hutch with whom the IRO interacts  
      • Be responsive to non-routine activities or information inquiries required by other departments such as legal, media affairs, the Office of the Director or investigator
    • Provide education and training for research teams and staff responsible for the conduct of human subject and/or laboratory animal research
      • Develop and maintain basic and refresher human and animal research ethics training in collaboration with the IRB Operations Manager and IACUC Analyst
      • Deliver human subjects training lectures and animal care and use training lectures as needed
      • Provide individualized training as needed
      • Assess ongoing training needs of Fred Hutch and Consortium members
      • Evaluate training effectiveness with Director
    • Oversee the IRO quality management system, including policy and procedure management, post-approval monitoring, etc.
      • Update IRO policies, procedures and education programs when federal regulations, policies or accreditation standards change
      • Work with IRO Director and QA Manager on AAHRPP accreditation documents and maintain active AAHRPP accreditation status
    • Evaluate funding proposals and provide certification of IRB/IACUC approval to funding agencies, as required in the absence of the IRO Director
      • Ensure timely review of scientific proposals undergoing institutional sign-off
      • Provide IRB and IACUC certifications to funding agencies when required

    Qualifications

    Minimum:

    • Bachelor’s degree; and either six years research protections experience or eight years Fred Hutch experience in a research administrative function; or equivalent combination of education and experience
    • Minimum 5 years prior supervisory or management experience
    • Knowledge of research-related policies and regulations, including FDA 21 CFR 50, 56; HHS 45 CFR 46; FDA 21 CFR Part 11
    • Excellent interpersonal, oral, and written communication skills
    • Must be highly detail-oriented and organized with intermediate knowledge of Microsoft Word, Excel, Outlook, PowerPoint, and SharePoint
    • Self-starter, able to work under minimal supervision
    • Sound judgment in high-demand situations
    • Experience working with an electronic IRB and/or IACUC system

     

    Preferred:

    • Demonstrated progressive responsible management experience in research regulation field
    • Certified IRB Professional (CIP)
    • Experience implementing electronic submission systems
    • Experience with process improvement methodologies and techniques
    • Experience with AAHRPP and/or AAALAC accreditation standards
    • Experience with audits and inspections conducted by outside agencies or accrediting organizations

    Our Commitment to Diversity

    We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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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