·Authoring or reviewing Clinical Study Protocols, Clinical Study Reports, and other regulatory submission documents (e.g., CTD Modules 2.5 and 2.7, and Integrated Safety/Efficacy Summaries Investigator’s Brochures, and briefing documents for regulatory meetings).· Analyzing and interpreting scientific/clinical data.· Executing comprehensive and systematic scientific literature searches, preparing and reviewing tabulated and written summaries of publications.· Quality control verification of documents.

Conducted an internship at the UNC Lineberger Comprehensive Cancer Center Clinical Trials Office, funded by the UNC ImPACT Program. Gained knowledge in clinical trial development, drafted and edited consent forms, IND applications, and administrative letters. Reviewed protocols and protocol amendments, and assessed IND applications for investigational products from UNC, external pharmaceutical companies, and CAR-T cell therapies. Participated in review meetings, including the Patient Advocacy for Research Council, Protocol Review Committee, and operational study team meetings. Completed an initial IRB application and attended lectures on clinical trial development, sponsor responsibilities, INDs, and clinical operations. Developed skills in medical and regulatory writing strategies to ensure compliance with FDA requirements for sponsor trials.