• Clinical Research Coordinator I/II--Infectious Disease Sciences

    Job ID
    13658
    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 I/II (CRC I/II) will coordinate day-to-day activities for assigned clinical research protocols for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting.

    Responsibilities

    The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Clinical Trial Program Manager and will be required to perform their responsibilities with independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks. The incumbent will some or all the following responsibilities:

     

    Study Conduct / Clinical Research Practice

    • Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
    • Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
    • Serve as project liaison, representing the project to other center departments, funding sources, affiliated individuals or institutions, and outside organizations.
    • On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
    • Collaborate with investigators and coworkers to ensure completion of study activities
    • Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
    • Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
    • Travel to University of Medical Center, Seattle Children’s, and Seattle Cancer Care Alliance will be required for the enrollment of study subjects.
    • Ensure accurate enrollment records are maintained and up to date.
    • Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
    • Create source documents or CRFs as needed to promote efficient data collection and entry.
    • Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
    • Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.


    Protocol Development and Implementation

    • Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans.
    • Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.


    Budget and Billing

    • Prepare requests for research prices on study activities and coordinate the research billing start-up process.
    • Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.


    Regulatory Compliance and Documentation

    • Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
    • Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
    • Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.


    Other duties which may be required:

    • Perform retrospective chart review as required
    • Travel for investigator meetings
    • Will require weekends and holiday coverage for clinical studies.
    • Other duties as assigned

    Qualifications

    • Clinical Research Coordinator I Minimum Education/Experience: BS or higher degree required in scientific/medical field. Previous work experience in a clinical research setting required.
    • Clinical Research Coordinator II Minimum Education/Experience: Bachelor’s degree in scientific/medical field or equivalent experience/education. Master’s degree in healthcare related field preferred, particularly in the area of epidemiology. Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field.
    • Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint and Access.
    • Knowledge using REDCap databases is desirable.
    • Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
    • Desire Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification

     

    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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