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needed. 5. Completes, audits, corrects case report forms. 6. Maintains documents as required by FDA guidelines. 7. May maintain contact with IRB and prepare and submit IRB documents. 8. May perform
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Procedures (SOPs) & Work Practice Documents (WPDs) Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB. Manages the workflow
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here: https://itacademy.harvard.edu/ . Job Description Job Summary Research, design, document, implement, configure, and validate solutions to business needs. Solve highly complex technical problems. May
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; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and
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Position Description We are hiring a research coordinator to facilitate the activities of grant-funded research (see https://sites.duke.edu/bablab/ ) and the Duke Interdisciplinary Behavioral
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, Institutional Review Board (IRB) submissions and renewals, regulatory compliance, data management, manuscript development, publication submission, grant preparation, and research timelines. The Research
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; distributing and tracking study devices and participant compensation; data collection and data entry; following IRB and human subjects policies and regulations; developing, updating, and managing study-related
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, solicitation or award-related concerns and issues. Coordinate with compliance offices (e.g. Export Control (EC), Financial Conflict of Interest (FCOI), Internal Review Board (IRB)) to ensure PI meets the minimum
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• Processing and shipping biological samples • Maintaining and entering data into research databases containing patient/participant information • Assisting or leading in the preparation and submission of IRB
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blood and other biospecimen collections, administering surveys, performing data entry, and carrying out quality assurance activities with minimal supervisory oversight. Strict compliance with IRB rules