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    Data Entry Clinical Research Trials - Los Angeles, CA, United States - CEDARS-SINAI

    CEDARS-SINAI
    CEDARS-SINAI Los Angeles, CA, United States

    3 weeks ago

    Cedars-Sinai background
    Description
    Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources.

    Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.

    Join our team and use your expertise with an organization known nationally for excellence in research studies.

    The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.

    Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.

    Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

    May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.

    Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

    Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

    In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; Maintains accurate source documents related to all research procedures.

    Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
    Schedules and participates in monitoring and auditing activities.

    Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

    Notifies direct supervisor about concerns regarding data quality and study conduct.

    Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

    May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.


    Working Title :
    Kidney-Transplant Clinical Research Coord II

    Business Entity :
    Cedars-Sinai Medical Center
    Academic / Research

    Overtime Status :

    EXEMPT

    Primary Shift :
    Day
    Shift Duration : 8 hour
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