• Clinical Quality Assurance Specialist

    Job ID
    13532
    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 Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Quality Assurance Specialist to join the Quality Assurance Team to provide quality support of clinical trial research. This position reports to the head of Quality Assurance.

    Responsibilities

    Works with the Quality Assurance Team to develop, implement, maintain and monitor the comprehensive quality management system (QMS), including: 

    • Internal Quality Audits 
    • External Audits and Inspections 
    • Vendor Audits 
    • Document Control 
    • Employee Training Program 
    • CAPA Implementation and Reporting 
    • System Validation Review and Archive 
    • Org Charts, CVs, Job Descriptions, Debarment Checks 
    • Change Management 
    • Quality Metrics 
    • Risk Management 
    • Continuous Improvement 
    • Projects and Initiatives
    • Record Maintenance 

     
    Performs other responsibilities as required. 

    Qualifications

    Minimum: 

    • Bachelor's degree with 2+ years of experience implementing elements of general quality assurance activities such as:
      • Preparation and/or participation in internal and external audits, maintenance of related records.
      • Identification and reporting of incidents/deviations, maintenance of related reports and documents, implementation of corrective and/or preventive actions.
      • Development of training materials, assignment of training, maintenance of training records and facilitating training to staff.
      • Review, development and/or revision of protocols/procedures, maintenance of controlled documents and related records.
      • Facilitation of or participation in qualifying suppliers and vendors, maintenance of related documentation.
      • Facilitation of or participation in the review of system validation documentation, maintenance of related documentation.
    • 3 years of progressive experience in implementing quality systems may substitute educational requirement.
    • Requires effective written and verbal communication skills.
    • Requires proficiency in MS Office Applications
    • May Require ability to travel on long or short term business trips.  

     
    Preferred: 

    • Bachelor's degree with 4+ years direct experience implementing quality assurance activities. 
    • 1+ year in a Senior or Lead quality role 
    • Experience using MasterControl 
    • Familiarity with Good Clinical Practices (GCP) in a clinical trial atmosphere 

    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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