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St. Louis

    Physician (Staff Neurologist) - Saint Louis, MO, United States - Medix™

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    Description
    We are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Neurologist to break into the Clinical Research field. The Principal Investigator responsibilities are centered around the execution, planning and management of assigned studies. Communicate succinctly with clients, study directors and technicians are key as is a cross-functional, flexible, and collaborative spirit. The Principal Investigator is responsible for the conduct of the clinical trial at a trial site

    Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
    Provide medical expertise and scientific feasibility for new sponsor inquiries
    Ensure that the safety and well-being of all participants in the study at the trial site are protected
    Ensure data collected at the study site is credible and accurate
    Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required
    Obtain and/or review participants' medical history
    Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
    Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants' safety—to sponsors and to the IRB as required by study specific reporting guidelines
    Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents

    Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.

    Ensure that the IRB is provided with a copy of the Investigator's brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
    Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator's brochure/product monograph and other documents provided by the sponsor
    Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
    Maintain trial documents as specified by guidelines and applicable regulatory requirements
    Ensure retention of essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product
    Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
    Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities
    Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason

    O with an active medical license (medical license must be valid in the state in which the research is conducted).

    Medical licensure (license must be valid in the state in which the research is conducted).

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