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    Clinical Records Representative - Irvine, United States - Planet Pharma

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    Upper Management / Consulting
    Description

    Pay $27-$29 per hr. DOE

    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 Edwards policies and procedures relevant to clinical study documentation
    • Basic knowledge of EW 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
    • 2-4 years of experience


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