Jamie has over 20 years of Clinical Research experience with a wide variety of knowledge and understanding of the industry. She has a strong understanding of ICH GCP and the ability to apply and understand the regulations as needed. She has more than 15 years in a leadership position. Jamie has experience leading and overseeing a team conducting internal and external audits, as well as site audits, with many of the sites and studies being conducted in many different areas of the world. She has experience in all phases of research and has an exceptional understanding of the drug development process. Jamie has a great deal of success and experience working across many functions, including clinical operations, PV, and regulatory teams to ensure successful projects. Jamie has extensive knowledge of GCP and Vendor Management, that includes CROs, Clinical Labs and other related services. She has extensive knowledge and application of Inspection Readiness policies and procedures she has hosted several successful FDA inspections, including a DCT inspection. She also has many successful IRB inspections as well as College of American Pathologist (CAP) and Association for the Accreditation of Human Research Protections Programs (AAHRPP) accreditations. Jamie has experience in successful acquisitions and mergers of Quality Assurance and compliance programs, corporate training teams, IRBs, and clinical research software solution companies.