Elizabeth Jay has over twenty years of clinical research experience in various roles within academic, Pharmaceutical, Biotech and CRO environments, augmented by nearly nine years of therapeutic experience as a nurse clinician in pediatric cardiology and as an intensive care nurse. Ms. Jay is an innovative individual with exceptional organizational and communication skills and a proven ability to lead, monitor and manage clinical trials.In her current position as a Principal CRA, Ms. Jay is responsible for monitoring avtivities associated with Phase I clinical trials.In her previous position, Ms. Jay provided leadership, training and guidance to the Phase I/Early Development monitoring group and manages 15 CRAs. She represented monitoring on a global Forum and provides input on all monitoring SOPs and WPs. In addition, Ms. Jay functioned as a member of the Functional Excellence - Monitoring group, focused on process improvement within clinical trial monitoring. She created the monitoring training curriculum and is responsible for onboarding. She is a Subject Matter Expert for IP management, has developed several trainings on this, and authored an update to the IP Accountability and Management GWP. She oveesaw a global team of monitors who review the Study Monitoring Plan for all Celgene-sponsored trials for consistent language and adherence to high standards for monitoring.Prior to her promotion to Manager, Ms. Jay was a Lead CRA/Principal CRA in Early Development Hematology/Oncology, where she proved herself as a leader and resource for her colleagues, repeatedly demonstrating expertise in understanding and monitoring complex protocols. Evaluations by her peers and managers consistently reflect exceeded expectations. She developed the curriculum for and co-led a three-day workshop for Lead CRAs and functioned as the North American leader of a global LCRA Task Force. She created a quarterly newsletter to promote consistency in monitoring practices, and now serves as an advisor to the LCRA Forum. Her dedication, expertise and passion for the patient make Ms. Jay a valuable asset.