20+ years in multiple aspects of clinical research. Experienced in clinical personnel management, data management, and site management. Experienced in monitoring for FDA and GCP compliance, and IRB administration. Experienced in protocol development, informed consent composition, EDC development and data analysis. Experienced in writing SOPs, work instructions and monitoring plans.Therapeutic Areas: HematologyOncologyCellular TherapiesCardiologyElectrophysiologyVascular InterventionHIV/AIDSMedical Devices
Listed skills include Research Project Management, Personnel Development, Medical Writing, Medical Devices, and 15 others.