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 files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements.

• 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: new project, mid-term report, amendment, and final report-Responsible for more than 10 IRB projects, 3 of them are subject recruitment studies• 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 ICH - GCP guidelines and regulatory guidelines

• 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 Australia clinical trial guidelines organization, in order to help regulatory strategy development• 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 different sites• 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

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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.