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The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Facilitates the preparation of Institutional Review Board applications for clinical research proposals. Demonstrates expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, GCP, OHRP, IRB, NIH/NCRR.
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Drafting Institutional Review Board documentation for research studies. MUSC Health, the clinical enterprise, operates a 750 bed medical center, which includes a nationally recognized Children’s Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of fewer than 70 elite National Cancer Institute designated centers), a Level I Trauma Center and the Institute of Psychiatry.
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Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents.
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Prepare and submit regulatory submissions to the Institutional Review Board (IRB). Serve as a subject matter expert in clinical research regulatory requirements and facilitate compliance with applicable institutional, sponsor and governmental policies and laws.
$65,000 - $72,000 a yearFull-timeExpandUpdated 28 days ago - UpvoteDownvoteShare Job
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Ability to gain knowledge and meet the reporting needs of UMB policies and practices for Institutional Review, Human Protections, Animal Protections, etc. Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies.
$56,000 - $62,000 a yearExpandUpdated 23 days ago - UpvoteDownvoteShare Job
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This role reports to the Law Vice President and Chief Corporate Counsel and includes legal support for matters relating to the Compensation and Human Resource Committee of the Board of Directors, SEC and other regulatory compliance and disclosure obligations, executive compensation and benefits, corporate governance and related matters to be assigned from time to time.
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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 yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Directs and participates in the development and submission of clinical research protocols and other documentation to the Institutional Review Board (IRB), local human research protection program, sponsors, monitors, and/or Food and Drug Administration (FDA.
$125,000 - $185,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Work in collaboration and consultation with Academic Affairs colleagues; the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC) and other academic and administrative offices as necessary in ensuring university compliance.
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The Director serves as the liaison for Campus Life departments and OPIER, Enrollment Management and Student Affairs (EMSA), Residential Colleges, and Institutional Review Board; and develops policies and procedures for project planning, review, data collection, analysis, interpretation, and dissemination of results.
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Assists in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities.
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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.
$37,220 - $53,188 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensure that proposals adhere to University, agency, and federally mandated requirements, including compliance with federal and international laws and guidelines governing clinical research, effort reporting, costing principles, cost sharing commitments, Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) approvals, and conflicts of interest.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Reports to the Director, Human Subject Protections (Director) and works closely with the IRB Coordinator I, Chair and members of the Institutional Review Board (IRB). Responsible for pre-review of items submitted for review by the IRB to confirm compliance with institutional, federal, and state policies.
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