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Cerritos

    Senior Regulatory Coordinator Clinical Research - Cerritos, United States - Oncology Institute, Inc.

    Oncology Institute, Inc.
    Oncology Institute, Inc. Cerritos, United States

    5 days ago

    Default job background
    Description
    Senior

    Regulatory

    Coordinator


    Responsibilities:
    Serve as the Regulatory Manager in the absence of the acting manager

    Maintains research practices using Good Clinical Practice (GCP) guidelines.

    Assists

    with auditing trials (Review and Preparation)

    Reviews and Submits Protocol Deviations and SAEs to IRB.

    Works directly with monitor and completes requests.

    Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

    Multi-task and prioritize effectively

    Organize multiple projects for efficiency

    Work efficiently and complete tasks with a high degree of accuracy

    Review IRB Portals for new approvals.

    File and maintain reg binder/e-Reg.

    Review DocuSign Portal and e-File documents.

    Prepare and complete the release of IND Safety reports for several trials.

    Assist

    in FDA and Sponsor Audits


    Skills & Abilities:
    Knowledgeable of FDA and QA audit processes.

    Strong interpersonal communication skills to interact with others effectively and diplomatically.

    Strong writte

    n com

    munication skills, ability to compose correspondence and

    maintain

    large file system.

    Typing and computer

    skill

    /ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).


    Education and Experience:
    Four or more (4+)

    year

    s

    experience


    with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed.

    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.

    Bachelor's Degree

    p

    referred

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