Julie Fazio, RN, BS is an experienced clinical research and GCP compliance professional with 12+ years in the research industry. She has conducted multiple audits for QualRS across the U.S. Midwest, supporting sponsors, CROs, and investigator sites with practical, inspection-ready quality oversight.

Julie’s experience includes GCP audits, FDA inspection preparation and on-site support, clinical monitoring, and clinical trial management. She is well-versed in U.S. FDA requirements and ICH E6 (R2) Good Clinical Practice, with working familiarity with EMA expectations. She partners with GCP clients to execute strategic compliance plans—identifying gaps, implementing corrective actions, and ensuring alignment with applicable regulations and internal SOPs.

Julie has supported clinical operations across the United States and internationally, including Canada, Spain, Germany, Hungary, and the United Kingdom, helping sites prepare for FDA and EMA inspections. She has completed hundreds of monitoring visits, audits, inspection-readiness visits, and on-site inspection support engagements.