• Regulatory Operations Coordinator

    Job ID
    12255
    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 department of Clinical Research Support (CRS) is the central clinical trials office for the University of Washington/Fred Hutchinson Cancer Research Center Cancer Consortium. The CRS Operations Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, institution-sponsored IND, and national cooperative group clinical trials. The position will prepare FDA and IRB documents and other study-related tools for the start-up and management of clinical trials, maintain regulatory files, and facilitate SAE processing. This position will report to the Regulatory Operations Manager.

    Responsibilities

    • Prepares and submits regulatory documents to the IRB to request initial, yearly, and protocol amendment approvals for industry sponsored, investigator initiated, institution sponsored IND, and national cooperative group clinical trials
    • Prepares and submits regulatory documents to the FDA to obtain initial protocol and amendment approvals for industry sponsored and institution-sponsored IND trials
    • 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
    • Establishes and maintains Cancer Consortium and Sponsor regulatory files
    • Facilitates SAE processing to comply with FDA reporting requirements for IND trials
    • Provides formatting and editing assistance for institution-sponsored IND trial documents
    • Extracts data from Institutional databases to report study accrual data
    • Extracts data from study data bases for scheduled and ad hoc reports for ongoing review of safety data, and IND annual reports

    Qualifications

    Required:

    • Bachelor’s Degree
    • 1-2 years working in clinical research environment
    • Clinical research related certification preferred
    • Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
    • Reviewing IRB documentation and research protocols
    • Writing technical documents
    • Ability to work collaboratively and build relationships across a large organization
    • Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
    • 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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