• Clinical Research Coordinator II, Immunotherapy

    Job ID
    14334
    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 Clinical Research Coordinator (CRC), Immunotherapy is responsible for day-to-day coordination of intervention Phase I-III clinical trials. The position will perform all tasks relating to the start-up, management and close-out of studies including: preparing IRB documentation, maintaining study records, screening patients for eligibility, tracking patient visits, and abstracting and reporting data. The Coordinator will work on multiple studies for one or more investigators, and report regularly to those investigators on the progress of the studies. The CRC II reports directly to the Clinical Research Manager.

    Responsibilities

    • Prepares study start-up documentation including IRB documents, eligibility checklists, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
    • Screens and registers patients; ensures eligibility requirements are met
    • Assures consent forms are completed correctly and in entirety
    • Schedules study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
    • Abstracts data from medical records to complete study-specific CRFs (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
    • Collaborates with study sponsor/consortium delegate to assist with study monitoring visits and responds to findings
    • Creates and maintains patient tracking tools; communicates status to investigators, management and relevant departments
    • Manages study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder
    • Liaises with study sponsor, investigator(s) and members of study team to communicate timelines, expectations and study status
    • Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
    • Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant brown bags, faculty and administrative presentations, and other opportunities of interest

    Qualifications

    • 2 -3 years’ experience in trial coordination and management is critical to success in this position, given volume, complexity, and compliance requirements in support of clinical trials
    • Undergraduate degree is mandatory, with master's degree preferable and/or equivalent experience at that level
    • Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
    • Ability to work with faculty and staff, including clinicians, and research scientists
    • Attention to detail and project management skills and experience
    • Well-organized and ability to juggle numerous tasks, often with conflicting and competing deadlines
    • Experience with study Data systems (Medidata RAVE, etc.) is strongly preferred

    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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