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    Senior Clinical Research Coordinator - Irvine, United States - Radiant Systems Inc

    Radiant Systems Inc
    Radiant Systems Inc Irvine, United States

    2 weeks ago

    Default job background
    Description

    Client: Major Medical Device Client

    Duration: 9+ months

    Location: Irvine, CA

    Actual Title: Senior Clinical Records Specialist

    Summary:

    The main function of a clinical records representative is to ensure accuracy and completeness of documents for clinical studies.

    Key Responsibilities:


    • Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision


    • Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines


    • Support team members during internal and external audits


    • Other incidental duties: May maintain and track study supplies

    Additional Skills:


    • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery


    • Good written and verbal communication skills and interpersonal relationship skills


    • Basic knowledge and understanding of Client policies and procedures relevant to clinical study documentation


    • Basic knowledge of Client GDP (Good Document Practice) SOP requirements


    • Ability to manage confidential information with discretion


    • Strict attention to detail


    • Ability to manage competing priorities in a fast paced environment


    • Ability to interact professionally with all team organizational levels


    • Must be able to work in a team environment, including inter-departmental teams


    • Ability to Provide feedback in a professional, direct, and tactful manner

    Education and Experience:


    • H.S. Diploma or equivalent Required


    • 5-7 years of experience

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