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    Clinical Records Representative - Irvine, United States - Ledgent Technology

    Ledgent Technology
    Ledgent Technology Irvine, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Summary:

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

    Sr Rep, Clinical Records

    Contract Duration - 9 Months

    Location - Irvine, CA

    Max Pay - $31.42

    Must haves for this role:

    -Well versed with Microsoft suite

    -Proven track required with quality control of documents and GDP practices

    -Prior experience uploading, pulling documents, and auditing documents in Veeva Vault

    -Comfortable with metadata and auditing for accuracy

    -For older trials, this team does work with paper files, and binder creation for site presentations

    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

    5-7 years of experience

    All qualified applicants will receive consideration for employment without regard torace, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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