Clinical Trial Operations Intern
• Prepared and drafted IRB documents for clinical trials, including informed consent forms (ICF), initial and amendment submissions, protocol deviation (PD) reports, and IRB closure reports.• Assisted CRA in conducting 8 on-site monitoring visits and performed Source Document Review (SDR) and Source Document Verification (SDV), reviewing Case Report Forms (CRFs) and issuing queries to the site coordinator (SC) for data clarification. • Participated in 1 Site Initiation Visit (SIV) and prepared Trial Master File (TMF) binders and essential documents.• Conducted a simulated Site Initiation Visit (SIV) presentation based on an actual study protocol and addressed questions from the study team, ensuring compliance with Good Clinical Practice (GCP) and protocol requirements.