• Monitoring Operations Manager

    Job ID
    14525
    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 Monitoring Operations Manager will be responsible for providing oversight of the administrative operations of the internal clinical research monitoring program. The incumbent will work under the direction of the CRS Regulatory Affairs and Compliance Assistant Director who manages the Monitoring Program.

    Responsibilities

    • Manages daily administrative and operational activities related to the monitoring and auditing of clinical research studies
    • Schedules monitoring activities in accordance with the Institutional Data and Safety Monitoring Plan
    • Develops Standard Operating Procedures (SOPs), materials, and tools which may include monitoring documents, study management/data collection instruments, and educational materials.
    • Guides the development of project and departmental procedures
    • May attend monitoring wrap-up meetings
    • Develops, reviews, edits, and revises tools used by the monitoring group
    • Provides ongoing guidance and assistance to study teams
    • Manages Clinical Research Resources Website (CRRW) SharePoint site
    • Produces special and recurring reports used by CRS management
    • Hires, trains, and supervises internal staff and contract clinical research monitors (CRAs) in conjunction with the Regulatory Affairs and Compliance Assistant Director.

    Qualifications

    Experience and Abilities

    • 5+ years working in a clinical research setting
    • Working with multi-disciplinary teams
    • Communicating with all levels of a research organization
    • Development of SOPs

    Knowledge and Skills

    • Bachelor’s Degree
    • ACRP or SOCRA certification
    • Supervisory experience required
    • Familiarity with process improvement principles
    • Strong written and verbal communication skills
    • Excellent organizational skills and attention to detail
    • Proficiency in Word, SharePoint, Excel, Acrobat, OneDrive

    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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