has vast experience with over 12 years in the research industry successfully completing audits, FDA inspection preparation and assistance, monitoring clinical trials, and clinical trial management. Julie is skilled in U.S. FDA, ICH E6 (R2) Good Clinical Practices (GCP) and the EMA. She works with GCP customers to execute strategic plans to identify, implement and ensure compliance with all regulatory and company SOPs. Julie has worked throughout the United States as well as Canada, Spain, Germany, Hungary and England prepping sites for FDA/EMA Inspections. She has completed hundreds of monitoring visits, audits, FDA inspection preparation visits and on-site assistance during FDA inspections. Julie is an enthusiastic, determined and a highly motivated individual who will be an asset to your team.