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Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
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The ORSC educates and supports the University research community with regulatory guidance concerning human subjects research (Institutional Review Board), animal research (Institutional Animal Care and Use Committee), use of biohazardous agents and use of recombinant or synthetic nucleic acids (Institutional Biosafety Committee), and financial conflict of interest in research (FCOI.
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Oversees adherence to regulatory requirements for study start-up, adverse event and protocol deviation reporting, ongoing reviews, and closeout activities in the timelines required by the study sponsor and the Institutional Review Board.
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Collaborates with the Project Director- Federal Grants, Director of Outcomes and Evaluation, and Clinical Director(s) to ensure compliance to project-specific outcomes and federal guidelines (e.g., reporting, Institutional Review Board.
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The Senior Clinical Research Coordinator acts as a liaison between the investigators in the United States, Colombia, and Jamaica, other collaborators, the Institutional Review Board, and government agencies.
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Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
$61,242 - $86,121 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
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We collaborate closely with our clinical research investigators and staff, our Institutional Review Board Office (IRB), and Research Compliance offices. We ensure compliance and optimal conduct of human research with relevant federal, state, and local regulations, Good Clinical Practice, and institutional policies.
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Work with the principal investigator to prepare and submit Institutional Review Board (IRB) documentation including continuing reviews, amendments, and adverse event reporting. Clinical Research Coordinator A/B (Department of Rheumatology.
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Stewardship of division resources (project staffing, skills training, space allocation), compliance and reporting requirements, regulatory reporting, and institutional review board (IRB) issues, and contracts.
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Work Performed Operations, Study and Site Management – 48% Effort Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews.
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Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). The CRC works to advocate for the patient, while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines.
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Promotes activities that meet Clinical Ladder criteria such as, an evidence-based practice/performance improvement project and/or a nursing theory-based, methodologic approach to develop a research proposal for Institutional Review Board (IRB.
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Assist in the preparation and submission of IRB protocol, consent form amendments and continuing reviews to the Institutional Review Board (IRB) The Division of Rheumatology, Allergy and Immunology (DRAI) at Massachusetts General Hospital (MGH) is seeking an intellectually curious and highly organized individual with supervisory experience to serve as a Research Project Manager in a clinical trial which will test two different treatment strategies for gout.
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Review Adverse Events and Serious Adverse Event with Primary Investigator within 24 hour of event report to Institutional Review Board (IRB) and sponsor. Certification of Clinical Research Coordinator, preferred.
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