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West Virginia University
Overview
The coordinator manages the development, monitoring, and implementation of pediatric clinical trials, including data collection and protocol adherence. They collaborate with multidisciplinary teams to educate staff and patients while ensuring regulatory compliance and accurate reporting.
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Compensation
Salary not listed
Posted
10 days ago
Coordinates and implements clinical research strategies and trials within the Department of Pediatrics, focusing on data collection and protocol adherence. Collaborates with multidisciplinary teams to manage drug titration, educate staff, and ensure regulatory compliance.
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The Regulatory Associate manages the development and maintenance of regulatory documents for clinical trials, including study start-up, IRB submissions, and close-out procedures. They also collaborate with clinical operations and sponsors to ensure audit-ready regulatory files and compliance with protocol requirements.
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The Associate is responsible for case initiation, data entry for non-expedited ICSRs, and performing quality reviews of safety data. They also support regulatory submissions and conduct reconciliation between vendor and internal safety databases.
4 months ago
