I worked closely with the PI to launch the research site at VGI and to coordinate clinical trials. Helped develop and implement SOPs and trained incoming employees. Assisted in the assessment of potential research studies and in preparation and execution of CTAs and budgets. Attended investigator meetings, prepared site for study start-up, collected essential documents, and handled IRB submissions. Handled application for hospital board approval and mediated between sponsor and hospital. Coordinated studies from start-up to close-out by developing CRFs and source documents, expanding recruitment, obtaining informed consent, reviewing subjects medical records, screening subjects for eligibility, maintaining regulatory and subject binders, reporting AEs and SAEs per regulations. Completed source documents and case report forms, updated medical records and EDC systems. CITI Good Clinical Practice training.