Yi-Syuan Li Email & Phone Number

• Site start up activities: complete site regulatory package documents, essential documents collection, and budget development with sponsor and/or CROs.
• Explain informed consent form and study procedure to subjects, and follow up subjects according to protocol schedule.
• Collects data from questionnaires and medical records, and enters data into electronic data capture system (iMedidata, NHRI CTIMeS).
• Clinical samples collection and processing.

．Collect and prepare documents for regulatory and ethics committee/IRB submissions. ．Communicate with investigators to obtain necessary documentation and information throughout the clinical trial on an ongoing basis, to meet the quality and regulatory requirements of the company/site/regulatory authority. ．Overall responsible to ensure appropriate project.

• Manage principal investigator-initiated human studies-handle multiple tasks with conflicting timelines, for example, responsible for more than 10 IRB projects-IRB project management and submission timeline management.
• Explain study procedure to subjects in studies and follow up subjects regularly-One of the studies enrolled more than 100 subjects
• Analyze epidemiology survey and clinical data from medical records statistically
• Qualified to ensure consistency of operational aspects of running studies.-participated in clinical trial training courses (total 30 hrs) and IRB training courses (total 48 hrs), which allows me to gain knowledge of.

• Collect and review research literature in a detailed and scientific manner.-Search for more than 10 competitive products' clinical trial information, and assist in design inclusion and exclusion criteria-Assist in.
• Assist in preparation of SOPs for study endpoint measurements.-Waistline measurement guideline and Body Composition Analyzer guideline for study research coordinators, to ensure consistency of operational aspects in.
• Vendor management and communication-Responsible for purchasing requisition and purchasing order of the department
• Ensure the clinical trial documents have been organized and archived to the system-Assist in public document writing, clinical trial center and CRO milestone payment, etc
• Handle multiple tasks with conflicting timelines and project management.

• Clinical samples collection, to ensure the lists of clinical samples well documented.
• Experimental materials preparation
• Assist in animal experiments

Bibliography search

Experimental materials preparation, Laboratory environment maintenance

Bachelor Of Science (Bsc), Life Science

Activities and Societies: Outstanding undergraduate thesis award: Identification of hypoxia-induced genes, INSIG1 and IDI1, that are.

Master Of Science (M.S.), Immunology

Activities and Societies: Thesis: Role of HIF-1α in NLRP3 and AIM2 inflammasome activation(advised by Professor Min-Zong Lai, Academia.