Clinical Trial: ◆ Site and vendor management for a clinical trial.◆ Prepare and review clinical trial documentation for submission to the IRB/TFDA, including Protocols, Informed Consent Forms (ICF), Investigator Brochures (IB), Case Report Forms (CRF), and patient materials.◆ TFDA/IRB submissions (original, modifications, and interim reports).◆ Negotiate site budgets and draft clinical trial agreements with investigators and sites.◆ Act as a liaison between the TFDA, the IRB, and the vendor for trial-related matters.◆ Prepare documentation for the trial, such as the ISF, TMF, SC working binder, and patient binder.◆ Conduct a site initiation visit (SIV), then write a confirmation letter, a follow-up letter, and a visit report.◆ Maintain the Investigator Site File (ISF) for accuracy, timeliness, and completeness.◆ Make the worksheets for the source data.The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device (特管法):◆ Site management.◆ Assist sites to create the essential documents, including Protocol, Informed Consent Forms (ICF), and cost-benefit analysis tables.◆ Complete the Ministry of Health and Welfare/CDE submission, including the initial submission and the response to comments.◆ Prepare related documents, including SC working binder, patient binders, and related worksheets, as well as annual reports, which include data collation and source data verification.

Study at Dr. Ding-I Yang’s lab◆ Handling of laboratory administration and accounting.◆ Explored the mechanism of Aβ-induced cell cycle reentry. ◆ This project resulted in the publication of a journal article. You can gain the full text with this link: https://doi.org/10.1016/j.bbamcr.2019.118628

Study at Dr. Su-Hang Zhuo’s lab◆ Explored the degree of methylation of specific genes in stroke patients.◆ Explored the mechanism of microRNA-x regulation in aging and blood-brain barrier.