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Definition of Reputation Credits
Yi-Syuan Li
• Responsible, cautious in attitude with an experience of two years as a research assistant in medical science and biotech company. Capable of time management to keep works in progress, effective communication and presentation skills. With knowledge of ICH-GCP, and qualified to ensure consistency of operational aspects of running studies.
• Having enthusiasm in medical science and not being satisfied with the status, I desire to move across into clinical trial research fields of taking on a role as clinical trial assistant to fulfill myself, make new contacts and broaden my experience.
Clinical trial assistant
New Taipei，TW
[email protected]
WORK EXPERIENCE
PlexBio Co., Ltd., Clinical Research Coordinator, Oct 2019 ~ Now
- 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. ．Collect and prepare documents for regulatory and ethics committee/IRB submissions.
- Assist in clinical trial execution, such as explain inform consent forms, fill in case report form, etc.
- Supervise daily operations and management of activities associated with the assigned project(s) from concept to completion of the final study report and ensure project goals are achieved.
Taipei Hospital, Ministry of Health and Welfare, Research Assistant, Nov 2017 ~ May 2019
- Collect and organize clinical data from electronic medical records and questionnaires in an accurate manner, and analyze epidemiology survey and clinical data statistically.
- Manage principal investigator-initiated human studies, including IRB project management and submission timeline management: which include new project, mid-term report, amendment and final report.
- Explain study procedure to subjects in studies and follow up subjects regularly.
- Qualified to ensure consistency of operational aspects of running studies.
Caliway Biopharmaceuticals Co., Ltd Taipei, Taiwan, Medical Affairs Department, Research Assistant, Feb 2017 ~ Aug 2017
- Review and organize research literature in a detailed and scientific manner: collect more than 10 clinical trial information of competitive products, in order to set up inclusion and exclusion criteria for clinical trials
- Prepare SOPs for study endpoint measurements.
- Responsible for purchase requisition and order of the department.
- Handle multiple tasks with conflicting timelines and project management.
Taipei Veterans General Hospital Taipei, Taiwan, Department of Obstetrics and Gynecology, Part-time Research Assistant, May 2013 ~ Jun 2014
- Prepare experimental materials.
- Ensure the lists of clinical samples well documented.
EDUCATION
NATIONAL YANG MING UNIVERSITY, Master of Science , Institute of Genome Science, 2014 ~ 2016
• Thesis: Role of HIF-1α in NLRP3 and AIM2 inflammasome activation(advised by Professor Min-Zong Lai, Academia Sinica)
• Relevant Coursework: Immunology, Molecular biology, Biochemistry
NATIONAL YANG MING UNIVERSITY, Bachelor of Science , Department of Life Science, 2010 ~ 2014
• Outstanding undergraduate thesis award: Identification of hypoxia-induced genes, INSIG1 and IDI1, that are regulated by TET1 (advised by Professor Kou-Juey Wu)
• Relevant Coursework: Biochemistry, Pharmacology, Immunology, Pharmacoeconomics
PROFESSIONAL TRAINING
GCP training courses (Total 30 hrs, 2016-2018)
Study Coordinator and Clinical Research Coordinator /Statistics Analyst/Auditor and Inspector Workshop
IRB training courses (Total 48 hrs, 2015-2019)
Human Trial & Research Ethics Workshop-Foundation Course/ Health Food/ Gene therapy and cell therapy/Database Research
Clinical Trial Research Associate Basic Training Course (Total 6 hrs, 2016)
Asthma Education Program for "Asthma Pay-for-performance Program" (Total 8 hrs, 2018)
SKILLS
Languages: Fluent in Mandarin; conversational proficiency in English (TOEIC 925: listening 450, Reading 475) Computer Skills: SPSS, FlowJo, Prism, imageJ, MS Word/Excel/Powerpoint/Outlook, Photoshop
Yi-Syuan Li
• Responsible, cautious in attitude with an experience of two years as a research assistant in medical science and biotech company. Capable of time management to keep works in progress, effective communication and presentation skills. With knowledge of ICH-GCP, and qualified to ensure consistency of operational aspects of running studies.
• Having enthusiasm in medical science and not being satisfied with the status, I desire to move across into clinical trial research fields of taking on a role as clinical trial assistant to fulfill myself, make new contacts and broaden my experience.
Clinical trial assistant
New Taipei，TW
[email protected]
WORK EXPERIENCE
PlexBio Co., Ltd., Clinical Research Coordinator, Oct 2019 ~ Now
- 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. ．Collect and prepare documents for regulatory and ethics committee/IRB submissions.
- Assist in clinical trial execution, such as explain inform consent forms, fill in case report form, etc.
- Supervise daily operations and management of activities associated with the assigned project(s) from concept to completion of the final study report and ensure project goals are achieved.
Taipei Hospital, Ministry of Health and Welfare, Research Assistant, Nov 2017 ~ May 2019
- Collect and organize clinical data from electronic medical records and questionnaires in an accurate manner, and analyze epidemiology survey and clinical data statistically.
- Manage principal investigator-initiated human studies, including IRB project management and submission timeline management: which include new project, mid-term report, amendment and final report.
- Explain study procedure to subjects in studies and follow up subjects regularly.
- Qualified to ensure consistency of operational aspects of running studies.
Caliway Biopharmaceuticals Co., Ltd Taipei, Taiwan, Medical Affairs Department, Research Assistant, Feb 2017 ~ Aug 2017
- Review and organize research literature in a detailed and scientific manner: collect more than 10 clinical trial information of competitive products, in order to set up inclusion and exclusion criteria for clinical trials
- Prepare SOPs for study endpoint measurements.
- Responsible for purchase requisition and order of the department.
- Handle multiple tasks with conflicting timelines and project management.
Taipei Veterans General Hospital Taipei, Taiwan, Department of Obstetrics and Gynecology, Part-time Research Assistant, May 2013 ~ Jun 2014
- Prepare experimental materials.
- Ensure the lists of clinical samples well documented.
EDUCATION
NATIONAL YANG MING UNIVERSITY, Master of Science , Institute of Genome Science, 2014 ~ 2016
• Thesis: Role of HIF-1α in NLRP3 and AIM2 inflammasome activation(advised by Professor Min-Zong Lai, Academia Sinica)
• Relevant Coursework: Immunology, Molecular biology, Biochemistry
NATIONAL YANG MING UNIVERSITY, Bachelor of Science , Department of Life Science, 2010 ~ 2014
• Outstanding undergraduate thesis award: Identification of hypoxia-induced genes, INSIG1 and IDI1, that are regulated by TET1 (advised by Professor Kou-Juey Wu)
• Relevant Coursework: Biochemistry, Pharmacology, Immunology, Pharmacoeconomics
PROFESSIONAL TRAINING
GCP training courses (Total 30 hrs, 2016-2018)
Study Coordinator and Clinical Research Coordinator /Statistics Analyst/Auditor and Inspector Workshop
IRB training courses (Total 48 hrs, 2015-2019)
Human Trial & Research Ethics Workshop-Foundation Course/ Health Food/ Gene therapy and cell therapy/Database Research
Clinical Trial Research Associate Basic Training Course (Total 6 hrs, 2016)
Asthma Education Program for "Asthma Pay-for-performance Program" (Total 8 hrs, 2018)
SKILLS
Languages: Fluent in Mandarin; conversational proficiency in English (TOEIC 925: listening 450, Reading 475) Computer Skills: SPSS, FlowJo, Prism, imageJ, MS Word/Excel/Powerpoint/Outlook, Photoshop