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Posting Details Position Information Job Title Senior IRB Analyst Position Number 500684 Vacancy Open to All Candidates Department AAH REDE Institutional Review Board Department Homepage https
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resource for investigators, supervisors, sponsors/CROs, IRB, ancillary departments, and institutional research partners; and may contribute to related start-up, data quality, coverage analysis, budget
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inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as
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source documentation and other required study records. Assist with IRB submissions, modifications, renewals, reports, and responses to regulatory or protocol-management issues. Coordinate and facilitate
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authorized by the IRB or institutional official. Conduct periodic compliance reviews of research protocols and documentation. Write reports and communicate findings with investigators, committees, and
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program at meetings, national and international research consortia. 7. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence. 8. Contributes
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of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test
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IRB submissions, amendments, consent forms, and continuing review materials Coordinate with UW offices (e.g., Human Subjects Review Committee, Grant and Contract Services, Environmental Health & Safety
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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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— helping coordinate study timelines and deliverables, tracking budgets and milestones, supporting vendor and field-site relationships, and keeping research operations on schedule and in compliance with IRB