• Regulatory Affairs Associate

    Job ID
    12178
    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 Regulatory Affairs Associate is responsible for providing support and guidance to investigators and others within the Cancer Consortium (Fred Hutch, UW, SCCA, Seattle Children’s) on regulatory issues and requirements related to the conduct of clinical trials and use of investigational products. The incumbent will facilitate communications with the FDA, provide support to study teams in the preparation and review of FDA submissions and other regulatory documents, and assist with FDA inspections. This position will represent the Regulatory Affairs Program to the Institution and Cancer Consortium by making presentations to staff, disseminating tools and information, and meeting with study teams and other departments on an ad hoc basis. The incumbent will work under the direction of the CRS Assistant Director, Clinical Research Regulatory Affairs and Compliance.

    Responsibilities

    Key Responsibilities

     

    • Provides regulatory consultation and support to investigators and staff throughout the lifecycle of a clinical trial
    • Advises, represents, and supports sponsor-investigators, clinical investigators, and staff for FDA interactions (correspondence, teleconferences, in-person meetings)
    • Provides operational support for FDA inspections
    • Coordinates and supports external audits that include assessment of Institution- or Consortium-level resources and processes
    • Reviews and edits complex submissions to FDA including IND/IDE applications, protocols, IND exemption requests, expanded access INDs, clinical hold responses, risk determination requests
    • Reviews and edits routine submissions to FDA including IND amendments, annual reports, and safety reports
    • Reviews investigator-initiated, FDA-regulated protocols for regulatory compliance
    • Reviews research team documents and templates related to regulatory compliance, including Corrective and Preventive Action plans
    • Advises CRS and Consortium Institutions on processes, guidelines, and best practices related to regulatory affairs
    • Develops internal processes, tools/templates, and standard operating procedures for the Consortium
    • Assists development of CRS training activities
    • Reviews and disseminates updated regulations and guidances
    • Maintains current regulatory expertise through training sessions, conferences, and participation in professional associations

    Qualifications

    Experience and Abilities
    • 3 - 5 years working in regulatory affairs with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting
    • Preparing and reviewing IND applications
    • Communicating with FDA and preparing for FDA audits
    • Assessing risk in the conduct of clinical research
    • Designing tools for the regulatory management of clinical trials
    • Interpreting federal regulations and guidelines
    • Working with all levels of a research team


    Knowledge and Skills
    • Bachelor’s Degree
    • Master’s degree (healthcare related field preferred)
    • Clinical research-related certification (certification is required within one year of hire)
    • Familiarity with process improvement principles
    • Excellent written and verbal communication skills
    • Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
    • Ability to work collaboratively and build relationships across large organizations

    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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