FDA Clinical Research Monitor & Submissions Lead
Vcu Rrtc
Virginia Commonwealth University (VCU) seeks an FDA program Administrator/Clinical Research Monitor to conduct risk-based monitoring and to develop monitoring plans for sponsor-investigator trials approved by the RDRC. The role involves authoring monitoring letters, CAPAs, and maintaining dashboards; providing training on Veeva SiteVault, eTMF and EDC, and supporting FDA and IRB submissions. Hybrid work arrangement and generous benefits are included. #J-18808-Ljbffr Vcu Rrtc
Vacancy posted 2 days ago
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