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Field
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Arrangement - This position has the option to be 100% remote. Candidates must reside in one of the approved states for remote work, which can be viewed here: https://remotework.duke.edu/policy/outside-nc
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IRB, GCP, and HIPAA (if applicable) guidelines Ensure adherence to protocol, IRB, GCP and HIPAA (if applicable) Ascertain that study staff are working within IRB, GCP, and HIPAA (if applicable
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testing, administrative duties and data management and will assist with IRB submissions. This study, funded by the UC Tobacco-Related Disease Research Program, is focused on investigating the cardiovascular
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to identify, evaluate, document, and report adverse events and safety concerns. Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports. Ensure
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timelines for new studies including IRB approval and contract execution, and the progress of ongoing studies, including enrollment. Identify barriers to study activation and enrollment and identify
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for assigned studies, preparing and overseeing IRB submissions (new applications, continuing reviews, amendments, reportable events, closures) and maintaining audit-ready regulatory files. • Coordinate
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, Clinical Research Center personnel, UNeHealth/SPA, accounting and IRB personnel to ensure optimal outcomes. Directs the research study team. Position Details Additional Information Posting Category
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information. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates. Understands the IRB submission and review process, and
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studies. Key Responsibilities and Accountabilities Data Management and Project Management Manage project administration activities, including Institutional Review Board (IRB) interactions, financial
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constructively with student researchers and leadership. Strong writing skills. Desired Qualifications* Clinical Research & Compliance: Direct experience drafting or managing IRB protocols, updating https