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In addition to the responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting.
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Will independently process Institutional Review Board (IRB) submissions and amendments. Reporting directly to Clinical Research Supervisor II, responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.
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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board(IRB). Scope: Protocol implementation & coordination Data collection, entry, reconciliation Patient interaction, procedures, scheduling Regulatory compliance & reporting Audit preparation Process improvement Other related duties as required.
$52,707.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.
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Assist with the training of staffDevelop preliminary designs for study related documentation of data and collection tools, ( questionnaires, treatment data and/or therapeutic checklists)Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processesAssist with financial /operational aspects of grant and contracts.
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The incumbent will be expected to follow Good Clinical Practice (GCP) and all organization policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.
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Coordinates and safely implements research activities through interactions with research staff, internal and external investigators, study sponsors and Institutional Review Board (IRB.
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Apply thorough knowledge of GCP (Good Clinical Practices), Institutional Review Board, and FDA (Federal Drug Administration) rules and regulations that apply to human subjects research.
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Duties include: Overseeing regulatory compliance issues such as tracking and recording protocol-specific certifications and procedure certifications such as Human Subject Protection and Health Insurance Portability and Accountability Act (HIPAA) Institutional Review Board approvals.
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Creates and revises study documents and applications per investigator, study team, HCC Protocol Review Committee (PRC) and MUSC institutional Review Board (IRB), and Food and Drug Administration (FDA) requirements.
$80,105 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Reports adverse events through appropriate sources per the policy of the protocol and the University Institutional Review Board (IRB) regulations. You will support life-changing research while building your expertise in regulatory and research protocol compliance, data collection, and patient care in a fast-paced, innovative environment.
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Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB.
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Ability to quickly learn and understand rules and regulations governing clinical research including "Good Clinical Practices", federal, state and university regulations for clinical research and Institutional Review Board guidelines.
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Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting.
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30%) Oversees work on the Medical Monitoring Project Assures adherence to the project protocol, serves as the Principal Investigator, ensures compliance with institutional review board requirements, data quality and security and confidentiality of the data collected.
$6,815 a monthFull-timeExpandApply NowActive JobUpdated 3 days ago
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