Julie Barnett has over 25 years’ experience in the biomedical industry, starting her career in 1997 at the site level before moving into Quality Assurance where she learned from auditors how to monitor for safety and compliance. She created and implemented process improvements in data handling and TMF/ISF filing for site and CRO personnel as  an internal monitor and compliance associate where she began her love of content creation and delivery to support protocol, SOP, and ICH GCP compliance before transitioning to the role of Clinical Research Associate (CRA) in 2000.  Passionately dedicated to patient safety and data integrity, she facilitated sponsor and investigator compliance with regulatory requirements for over seventeen years as a regional CRA. Through engaging training sessions, detailed documentation, and proficient communication skills she fostered global compliance with ICH GCP, governing SOPs and trial-related documents  while promoting ambitious standards for continual improvement. She created a CRA mentoring program and conducted training and assessment visits to fellow CRAs before accepting a promotion to the new position of Global Clinical Trainer in 2017 where she created, delivered, and managed a global CRA Training Academy for both research naïve and industry experienced professionals to become qualified CRAs. She earned accreditation as an Internationally Qualified Clinical Research Trainer in 2020, hosted and presented an external Audit Academy, and presented training material and global sessions on soft skills, corporate and new hire onboarding, role-specific, departmental, global regulatory guidelines and annual ICH GCP training in addition to supporting audits and regulatory inspection preparation, conduct, and follow up. Building on years of experience in clinical operations and quality assurance, she is enthusiastic about empowering teams to succeed through quality training, inspection-ready documentation and continuous improvement culminating in the creation of Critical to Quality (C2Q) Consulting LLC in 2024.