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Field
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, including the development of graphs and tables Drafting, editing, and distributing technical publications, reports, and manuscripts Drafting, submitting, and tracking IRB-related functions. Conducting
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Beaker and LabMatrix Be the compliance and liaison hub Partner with researchers to build Statements of Work and budgets, ensuring IRB approvals, patient consents, pathology reviews, and CLIA authorizations
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accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, case report forms (CRF's), drug dispensing logs, and study
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, site PIs, site coordinators, trainees, vendors, consultants, sponsored projects teams, and other collaborators Regulatory, IRB, NIH Reporting, and Compliance Serve as the central regulatory coordinator
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partnerships to execute Participate in CRF testing and possibly design. Regulatory Responsibilities Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions
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Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by
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conducted in partnership with internal and external entities Establish and oversee research operations, governance, and methodological standards, ensuring compliance with IRB requirements, FERPA, ethical
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University of North Carolina at Chapel Hill | Chapel Hill, North Carolina | United States | about 1 month ago
budgeting tools to enable accurate forecasting and reconciliation of site and subject payments. This position may assist in preparation of documents required for IRB initial and continuing review (IRB
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rules, regulations, and requirements of IRB, IACUC, COI, IBC and Misconduct in Science. Clearly communicate with faculty to inform them of obligations in meeting federal requirements when
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assigned. • Ensure data integrity in oncore, box and REDCap and support dissemination of research findings. Regulatory Compliance and Administration (15%) • Prepare and manage Institutional Review Board (IRB