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    Senior Clinical Trial Assistant - London, United Kingdom - ICON Strategic Solutions

    ICON Strategic Solutions
    ICON Strategic Solutions London, United Kingdom

    1 week ago

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    Description
    Senior Regional Clinical Research Associate

    The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

    Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;

    • Validating product performance claims;
    • Supplying data for critical Regulatory submissions;
    • Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.
    Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures
    Excellent planning, organizing, and interpersonal skills. Demonstrated experience in computer skills to include Microsoft Office, and basic templates. Medical laboratory experience stipulation. General clinical trials experience/deep understanding.
    Must be able to travel within UK and EU region on occasion.
    Minimum - Bachelor's degree in science or relevant field.
    Medical technology degree preferred, but not required if R&D background is adequate
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