• Institutional Review Analyst, Expedited

    Job ID
    12157
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Administrative Support
  • 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 with minimal side effects. 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 Board (IRB) Expedited Analyst is an advocate for the protection, rights, and dignity of people who are part of research studies at Fred Hutchinson Cancer Research Center. Primary responsibilities for this position include:

    1. Comprehensive analysis of expedited research studies for compliance with regulations, guidelines, and institutional policies
    2. Efficient review, processing support, and documentation for all submissions
    3. Respectful, collaborative relationship with all stakeholders
    4. Support the IRB team by performing all functions of an IRB Committee Analyst as back-up

    Responsibilities

    1. Comprehensive analysis of expedited research studies for compliance with regulations, guidelines, and institutional policies
    • Analyze submissions qualifying for expedited review for completeness and compliance, using screening forms, historical records, and other resources
    • Gather additional data as necessary from researchers, study staff, and others
    • Advise researchers of submission problems and suggest solutions
    • Advise and provide input to IRB Chairs and other stakeholders regarding regulations, rules and intent, and compliance options
    1. Efficient review processing support and documentation for all submissions
    • Compose and internally route result letters that relay expedited reviewer requests to investigators
    • Perform reviews of study documents for completeness and consistency
    1. Respectful, collaborative relationships with all stakeholders
    • Respond to IRO related questions and concerns initiated by stakeholders
    • Serve as liaison between the IRO and research study staff by exchanging information as part of the day-to-day processing of submissions
    • Provide advice and support to the IRB Chairs and stakeholders
    1. Serve as a back-up for IRB Committee Analysts and perform all the functions of an IRB Committee Analyst as necessary. When necessary for IRB operations, the Expedited Analyst may be asked to perform all the duties of an IRB Committee Analyst including:
    • Analyze submissions requiring full IRB review for completeness and compliance, using screening forms, historical records, and other resources
    • Gather additional data as necessary from researchers, study staff, and others
    • Advise researchers of submission problems and suggest solutions
    • Advise and provide input to IRB Chairs and other stakeholders regarding regulations, rules and intent, and compliance options
    • Communicate with IRB Committee members in order to establish quorum and assign protocol reviews
    • Develop agendas and attend monthly and emergency IRB meetings
    • Prepare e-Review agenda for all Full Review items
    • Compose and internally route result letters that relay committee requests to investigators
    • Perform reviews of study documents for completeness and consistency
    • Respond to IRO related questions and concerns initiated by stakeholders
    • Serve as liaison between the IRO and research study staff by exchanging information as part of the day-to-day processing of submissions

    Qualifications

    Minimum qualifications:

    • Bachelor’s degree; and either two years Institutional Review/Human Subjects experience OR four years Fred Hutch experience in administrative support to research projects/grants; or equivalent combination of education and experience
    • Must demonstrate effective written and verbal communication skills
    • Attention to detail required
    • Ability to work independently and as part of a team
    • Proficient in word processing and previous experience with MS Office programs (MS Word, Access, Excel) required
    • Ability to lift 25 pounds
    • Must be able to read a physical document

     

    Preferred qualifications

    • Prior experience as an IRB Analyst
    • Certified IRB Professional (CIP)
    • Working knowledge of federal regulations applying to IRBs, including 21 CFR 50 and 56, and 45 CFR 46

    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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