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collaboration with the Principal Investigator (PI). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation
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engagement, regulatory activities, data management, and study coordination. This role offers the opportunity to develop expertise in clinical research while contributing to studies that advance knowledge and
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to the Duke EHR. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Screens participants for complex studies (e.g., procedural and interventional
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. Familiarity with model explainability techniques such as saliency mapping and Grad-CAM. Ability to contribute to study design, hypothesis development, and innovative research initiatives. Why Duke? At Duke
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, storage, tracking, accountability, and participant dispensing. Serve as a primary liaison among sponsors, investigators, regulatory offices, research support services, and study teams. Prepare and maintain
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. This role provides an opportunity to develop and expand clinical research expertise while contributing to studies that advance new treatments, technologies, and approaches to improve outcomes for patients
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maintain regulatory documentation throughout the study lifecycle. Develop and submit IRB applications, amendments, continuing reviews, and reportable events through iRIS. Coordinate FDA submissions and
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an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Participates in or leads development of monitoring and audit training sessions
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regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Prepares for and provides
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, including syllabi collection and final project reports. Curriculum & Faculty Coordination Lead the planning and development of the course schedule each semester, assessing enrollment trends and collaborating