Faculty Bios

Clinical Research Monitoring and GCP Virtual Workshop for Monitors, Site Coordinators and Auditors 

Gretchen Gall

Gretchen Gall is a Senior Manager in Clinical Operations at Amgen (formerly Horizon Therapeutics, a biotech company specializing in rare disease. Companies that she has worked for include, IQVIA Biotech (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, operational strategy and biding, 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 21+ years of experience in the industry including experience in project operations management, clinical trial management, monitoring, FDA audits, process improvement, and ICH/GCP training.

James Simmer

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.