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    Senior Regulatory Coordinator - Los Angeles, United States - University of California

    University of California
    University of California Los Angeles, United States

    3 weeks ago

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    Description
    Make a positive impact on one of the nation's top health systems. Help ensure the efficient delivery of award-winning patient care. Take your professional expertise to the next level. UCan do all this and more at UCLA Health.
    The Senior Regulatory Coordinator plays a critical role in the overall pre-activation operations and regulatory aspects of clinical research.

    The incumbent is an experienced professional who will have direct responsibility for the implementation and activation of start-up activities for various studies including multi-center trials (both NIH and industry-sponsored) and investigator-initiated clinical trials.

    As the Senior Regulatory Coordinator, you are responsible for the oversight of all the regulatory aspects of clinical research studies from pre-activation to closeout.

    This includes the preparation, maintenance and submission of regulatory files to the appropriate parties (IRB, FDA, Medicare, Ancillary services, Scientific Review Committees, etc.) to fulfill research requirements and compliance with the applicable laws and regulations.

    You will coordinate, track, report on and develop strategies and processes related to study start-up, successful regulatory management of clinical trials, budget negotiation and coverage analysis.

    Work with study monitors to process, review and collect the appropriate regulatory documents in a timely manner.

    Qualifications * At least 3 years of Clinical Research Regulatory Affairs experience - required

    • Bachelor's degree in related field - required
    • Ability to organize multiple projects for efficiency and cost-effectiveness
    • Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings
    • Ability to work flexible hours to meet study deadlines and requirements
    • Advanced knowledge of Institutional Review Board, Internal Scientific Peer Review Committee, Contracts and Grants and CRU policies and procedures
    • Computer skills using PC platform computers with proficiency in Excel, Word, FileMaker pro to enter data and generate correspondence accurately
    • Strong interpersonal communication skills to effectively and diplomatically interact with others, including institute leadership
    • Strong written communication skills, ability to compose advanced correspondence and manage large file systems
    • Sufficient math ability and knowledge of clinical trials budgeting processes to manage the preparation of clinical trial budgets
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