Responsibilities include supporting regulatory submissions, maintaining essential regulatory documentation, and ensuring compliance with study protocols, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, U.S. Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, the Common Rule (45 CFR 46), HIPAA, applicable federal and state regulations, and organizational policies and procedures. Maintain regulatory binders, electronic regulatory files, investigator/site regulatory records, and essential documents, including investigator qualifications, training records, financial disclosures, delegation logs, laboratory certifications, and other required documentation in accordance with ICH-GCP and organizational SOPs.