A Senior Clinical Research Associate II and founder of an independent clinical research consultancy, with 28+ years of experience across drug and device research, Phases I–IV, and more than a dozen therapeutic areas. Andrea brings a uniquely dual perspective to clinical research education — having spent the first half of a career in site-level leadership as a Clinical Research Coordinator and Site Director, and the second half as a Senior CRA II with globally recognized CRO and Sponsor organizations including Quintiles (now IQVIA), Syneos Health, Pfizer, AbbVie, and PAREXEL.

This dual experience — on both sides of the monitoring table — forms the foundation of a methodology dedicated to bridging the gap between GCP theory and audit-ready site execution. Areas of expertise include ICH E6(R3) implementation, site infrastructure development, investigational product management, and advanced documentation standards for clinical research sites.

Session:

• ICH E6(R3) and Principal Investigator Oversight: Beyond the Delegation Log