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    • Clinical Research Coordinator I - Seattle - Fred Hutchinson Cancer Center

    Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center Seattle

    4 weeks ago

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    Description
    Clinical Research Coordinator

    Clinical Research Coordinator to join dynamic team of dedicated and skilled research staff working on clinical trials in the field of hematologic malignancies. The Clinical Research Coordinator will participate in the planning, coordination, and implementation of multiple industry-sponsored and investigator-initiated oncology clinical trials involving human subjects.

    This role will have the opportunity to work partially at our campus and remotely. The Clinical Research Coordinator will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.

    Responsibilities:

    • Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
    • Review study candidates' medical records in detail for study eligibility.
    • Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
    • Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
    • 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.
    • Monitor and track upcoming patient visits. Initiate scheduling of patient clinic visits, and on-going study visits. Attend patient visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
    • Collaborate with Investigational Drug Services (IDS) and/or Nuclear Medicine on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
    • Ensure study drug self-administration and accountability with patients, perform non-clinical ECGs, administer study questionnaires and other protocol-driven non-clinical assessments.
    • Function as a protocol liaison with clinical teams, patients, consortium partners, other institutions, and sponsors when necessary.
    • Coordinate monitoring visits and respond to queries and other requests from study monitors.

    Data Coordination and Abstraction:

    • Work independently to obtain, abstract, code and enter complex clinical information from multiple sources (medical records, research records, etc.) for research subjects into various study-specific electronic data-capture systems in according to contractual timelines.
    • Resolve and answer data queries with minimal errors.
    • Understand research study flow and work with other team members to perform the required research support tasks at appropriate study appointments.
    • For some research studies, independently request copies of radiology images, complete requisition forms and submit to pharmaceutical companies.
    • Develop study-specific data acquisition forms.
    • Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.

    Administrative:

    • Collate and establish study-specific research and reference binders.
    • File requisitions and other research documentation in each patients' research chart.
    • Independently screen third party safety reports and submit to PI for review.
    • Complete and collect required regulatory documents for submission to pharmaceutical sponsors, internal review committees, and other regulatory authorities.
    • Assist with maintaining regulator folders in the electronic Binder system.

    Qualifications:

    • High school diploma or equivalent.
    • Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
    • Demonstrated knowledge of how to synthesis study conduct.
    • Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
    • Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
    • Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
    • Bachelor's degree or equivalent experience is preferred. 2+ years of oncology clinical research or relevant/related experience is also preferred. CCRP or CCRC accreditation is also preferred. Prior experience in oncology research, prior exposure to CTMS, Florence, and/or EDC platforms is also recommended. A self-starter with the ability to locate resources and operate productively in an environment where standard operating procedures, guidelines and policies are not always available. Must have the flexibility to manage patients visits that may occur before or after regular work hours. Flexibility with work schedule required as required in-person work will be driven by research patient visits, which will be variable.
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