Julie Gawith, MSN, RN, CCRA

Clinical Operations & Compliance Consultant

Julie Gawith has over 23 years of broad clinical research experience, focused on high-quality deliverables. She is a process improvement leader, with proven success in implementing and supporting new operational initiatives for small organizations to ensure quality, compliance, and inspection readiness. She has also worked on all phases of clinical studies, in many therapeutic areas, with adult and pediatric populations. 

The majority of Julie’s recent clinical experience has been working with sponsors and large CROs in early development on complex oncology trials. Additionally, she has expertise in managing multiple aspects of clinical study conduct including, site coordination, study team leadership, site management and monitoring, Trial Master File set-up and maintenance, Computer System Validation, vendor management, and various quality initiatives.