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-based reporting, long-term modeling, budget development tools, sponsored research analytics, and the development of business plans for new programs and initiatives. Responsible for supporting
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or devices. Not permitted to tee up orders for second signature in Maestro Care. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g
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activities. Act as a preceptor and support the development of other staff and students. Complete necessary documents for patients (i.e. forms, FMLA) Perform other related duties incidental to the work
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. Independently conducts literature searches and reviews. Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications. Ensures
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others. Assists with the development of consent plans and documents for participants. Develops and submits documentation for IRB review in iRIS. Communicates with the IRB staff and reviewers and handles
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the development of Duke Arts’ artist residency programs, designing educational models that guide Duke Arts’ engagement strategy across campus with a focus on faculty collaboration, creative research, and arts
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. Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development
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. · Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. · Assists with the development of consent plans
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appropriate parties. May prepare Federal Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and
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development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others