![]() Manage central enrollment of all study subjects.Prepare sites for study start-up by reviewing and tracking regulatory documents, ordering study start-up supplies and conducting site initiation visits.Coordinates and track regulatory, data management, DSMB, SAE submissions.Develop and maintain study operations manual.Assist in the coordination of site budget and sub contract development.II trials coordination with peer investigators and institutions.Multi-Site The multi-site project management team provides data management and clinical monitoring support for multi-site trials coordinated by the CTSU from trial start-up through trial closeout. Regulatory liaison between study team/sponsor/IRB.Liaison with internal and external audits, including FDA.Management of outside drug safety letters, reports.IRB submissions (Initial Approval, Amendments, Renewals, SAEs, DSMR’s ORIOs).The regulatory team works closely with the projects to understand their support requirements and ensure those requirements are delivered according to GCP’s and the relevant CTSU Standard Practice Guidelines. Regulatory The CTSU Regulatory team ensures regulatory compliance during the conduct of clinical research studies via appropriate management of clinical study documentation as well as actively supporting the all regulatory aspects of clinical trials start-up, conduct and close out. Coordinate IDS monitor visits, patient registrationĬlick for more information and virtual facility tour. ![]()
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