Ethan Wu
Clinical Trial Associate
Taipei
Summary
Senior Clinical Research Associate with extensive experience at BeiGene Taiwan, excelling in cross-functional teamwork and analytical problem-solving. With 11 years of CRA experience, during which I cooperated in project management with assigned tasks, including CSR review, performing all types of Monitoring Visits, including PSV, SIV, IMV and COV with 100% or reduced SDV and remote SDR, participated in sponsor audits and TFDA inspections.
My past clinical trial experiences included both blinded and unblinded monitors of about 30 clinical trials in various therapeutic areas, including cardiology, hematology, infectious disease, metabolism, nephrology, oncology, ophthalmology and rare diseases.
I am familiar with different clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries. Proven track record in ensuring subject safety and supporting TFDA inspections, while effectively coordinating site staff training and query resolution.
Overview
12
12
years of professional experience
7
7
years of post-secondary education
2
2
Languages
Work History
Sr. CRA
BeiGene Taiwan
12.2023 - Current
- Performed Initiation, Interim, and Close-out monitoring visits.
- Performs by 100% SDV during on-site visits using EDC.
- Uses IVRS for IP set-up and management, and in house local CTMS system for reporting.
- Reviews on-site Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting and follow-up.
- Maintains regular site staff contact, training and query resolution support. Participated in mentoring, coaching and newsletter writing.
- Supports TFDA inspections.
SENIOR CRA
PPD
05.2016 - 05.2022
- Performed Feasibility, Initiation, Interim, unblinded and Close-out monitoring visits.
- Performs 100% or risk-based SDV during on-site and remote visits using EDC.
- Uses IVRS for IP set-up and management, and in house local CTMS system for reporting.
- Reviews on-site Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting and follow-up.
- Maintains regular site staff contact, training and query resolution support.
- Participated in sponsor audits.
CRA
Novartis
12.2015 - 04.2016
- Performed start-up activities.
- Reviewed on-site Investigator files.
- Used IVRS for IP set-up, accountability, and management.
- Maintained regular site staff contacts, trainings.
CRA
Seriver
06.2015 - 12.2015
- Performed Interim monitoring visits and close-out visits.
- Performed 100% SDV during on-site visits using EDC and in-house local CTMS system for reporting.
- Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up.
- Used IVRS for IP set-up, accountability, and management.
- Maintained regular site staff contacts, training, and query resolution support.
CRA
QPS-Qualitix
03.2013 - 05.2015
- Performed Feasibility, Initiation, Interim, unblinded and Close-out monitoring visits.
- Performed 100% SDV during on-site visits using EDC. Used IVRS for IP set-up and management, and in house local CTMS system for reporting.
- Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up.
- Maintained regular site staff contact, training and query resolution support.
Education
Master of Science - Biochemistry
Institute of Biochemistry Science
Taipei 08.2002 - 07.2004
Bachelor of Science - Biology
Department of Plant Pathology And Entomology
Taipei 08.1996 - 07.2001
Skills
Cross-Functional Teamwork
Effective Task Coordination
Accountable Professional
Analytical Problem-Solving
Adaptable Problem Solver
Timeline
Sr. CRA
BeiGene Taiwan
12.2023 - Current
SENIOR CRA
PPD
05.2016 - 05.2022
CRA
Novartis
12.2015 - 04.2016
CRA
Seriver
06.2015 - 12.2015
CRA
QPS-Qualitix
03.2013 - 05.2015
Master of Science - Biochemistry
Institute of Biochemistry Science
08.2002 - 07.2004
Bachelor of Science - Biology
Department of Plant Pathology And Entomology
08.1996 - 07.2001
Similar Profiles
Esther XuEsther Xu
Intern at BeigeneIntern at Beigene
Brian J. GossBrian J. Goss
Associate Director of QA Validation at BeiGeneAssociate Director of QA Validation at BeiGene
Korrin SeaveyKorrin Seavey
Senior Account Manager at BeiGene CorporationSenior Account Manager at BeiGene Corporation