Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors
Course faculty would be one of the following instructors.
Gretchen Gall is a Clinical Operations Manager at Novella Clinical, an international CRO focused on the unique needs of oncology, medical device, and dermatology sponsors. Companies that she has worked for include, Novella Clinical, Astellas Pharmaceuticals, and Novo Nordisk Inc. Additionally, she has been a consultant in the clinical research industry specializing in monitoring services, research site development, and audit preparation. Ms. Gall began her career in clinical research interning at a research site assisting with data entry and regulatory management. In 1999, she began her professional career in clinical research as a CRA. Ms. Gall brings 20 years of experience in the industry including experience in project operations management, clinical trial management, monitoring, FDA audits, process improvement, and ICH/GCP training.
Jim Simmer is founder and President of Research Answers, a clinical research consulting company whose mission is to assist physicians develop clinical research programs based on sound structure, consistency, efficiency, and accountability. Prior to founding Research Answers, Jim held positions as a Clinical Research Associate, then project manager in the pharmaceutical industry. After obtaining his MBA from Temple University, he was Research Director within a large medical center as well as a physician private practice.