• Regulatory Assistant

    Job ID
    10949
    Type
    Temporary Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    The Regulatory Assistant performs general administrative research duties to assist with start-up and maintenance activities for National Clinical Trials Network (NCTN) studies. This position is responsible for interpreting policy, representing the department, and interacting daily with Cancer Consortium personnel (i.e. research team members, faculty, and other health care personnel) and outside organizations. This position must have the ability to work on multiple tasks and projects at any given time.  The position reports to the Regulatory Operations Manager.

    Responsibilities

    • Process existing and new investigator credentialing documents in order for them to participate on research studies
    • Process research and clinical personnel changes in order for them to participate on assigned research studies
    • Inputting data in various web applications and portals    
    • Collect, revise and maintain files of regulatory documents and protocol specific training documentation
    • Facilitate the execution of required regulatory documents, such as obtaining signatures
    • Process regulatory changes and communicate updates to study personnel
    • Interface with external websites and databases to identify study changes
    • Update internal databases used to track regulatory related documents 
    • Maintain communication distribution lists
    • Maintain paper-based and electronic study files
    • Perform other related activities as assigned

    Qualifications

    Required Experience and Abilities

    • Competency in Microsoft Office software
    • Excellent organization skills and acute attention to detail
    • Ability to communicate effectively both verbally and in writing  
    • Demonstrated ability to work independently, under supervision, and be a team player
    • Ability to adapt and respond appropriately to competing priorities in a fast-paced environment; able to meet deadlines

     

    Preferred

    • Bachelor's Degree in a related field of study
    • 1-2 years of related experience in a clinical or research setting
    • Experience with databases or data entry
    • Knowledge in medical terminology, research and oncology
    • Previous regulatory experience

    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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