Wanda Ewing

Clinical Research Monitor Ii @University Hospitals

Cleveland, OH, US

Requires Advanced Degree and a minimum of 3 years of Clinical Research Management experience including sound knowledge of US regulatory requirements for clinical research including: FDA, ICH, GCP. Coordinate activities within the Quality Assurance Program for the Clinical Research Unit. Perform extensive quality assurance review of study documents and data across multiple complex studies of different therapeutic areas and phases and report findings to management and research team. Assist in regard to specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Establish and implement process improvement projects. Ensures that clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. Create and maintain an education and training program for the Clinical Trial Unit.