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    Regulatory Coordinator - Cerritos, United States - Medix

    Medix
    Medix Cerritos, United States

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Responsibilities:

    • Maintains research practices using Good Clinical Practice (GCP) guidelines.
    • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
    • Handle confidential material with judgement and discretion
    • E-filing and sorting from DocuSign to Trial folders on G-drive.
    • Reviews ICF completion, to verify documentation completed properly.
    • Releases ICF due to requests from Study Coordinator.
    • Prepares and releases documentation for training for New Amendments, New
    • IB's, Protocol Letters and or clarifications among other training document preparation.
    • Documents research staff and investigators initial participation on trial and releases documents.
    • Tracks and logs pending documents efficiently.
    • Request Certification for new research staff and Investigators.
    Education and Experience:
    • Associates Degree or one or more (1+) years experience with regulatory documents.
    • Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).
    • Demonstrated experience with multi-study and multi-site clinical research activities.
    • Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
    • Demonstrated knowledge of FDA and Sponsor regulatory requirements.
    • Knowledgeable of FDA and QA audit processes.
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