Huang Peixu
CRA
Guangzhou
Summary
Accomplished Clinical Research Associate with 6 years of experience performing and documenting Pre-Study Selection Visit, Study Start-up, Site Initial Visit, Interim monitoring and Study close-out visits.Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. Evaluated as Performance Excellent in 2023 in BeiGene.
Overview
6
6
years of professional experience
4
4
years of post-secondary education
2
2
Certifications
3
3
Languages
Work History
Clinical Research Associate
BeiGene, Ltd.
Guangzhou, Jiangxi
2022.06 - Current
- Perform PSSV, SIV, IMV, COV in multiple study such as phase II(SCLC, LN) and phase III(GEA, NPC, MZL FL) according with MP and regulatory requirements.
- Ensure the quality and integrity of study delivery at trial sites, adherence to the study protocol, management plans, SOPs and applicable regulations. (Focus on sites in Guangdong, Guangxi)
Study Start-Up Specialist
BeiGene, Ltd.
Guangzhou, Jiangxi
2020.04 - 2022.06
- Delivery of clinical start-up component of assigned studies with accountably for time, cost and quality for assigned activities.(10 EDPs per year)
- Clinical trial site contract and budget negotiation in different area sites(Guangdong, Fujian, Guangxi etc.)
Clinical Research Coordinator
Guangzhou Medsi Medical Technology Co., LTD
2018.09 - 2020.04
- Responsible for phase II/III studies in Oncology, Respiratory to deliver the study quality per protocol.(Site in Sun Yat-sen memorial hospital and The First Affiliated Hospital of Guangzhou Medical University)
Education
Bachelor of Science - Pharmaceutical Engineering
Wuhan University of Bioengineering
Wuhan, China 2014.09 - 2018.09
Skills
- Ability to monitor study sites independently according to protocol, SOPs, GCP and ICH guidelines
- Negotiate with site contract and budget per sponsor requirements
- Perform PSSV, SIV, COV independently as required
- Workable in English
Certification
CET-6
Timeline
NMPA GCP Certificate
2022-12
Clinical Research Associate
BeiGene, Ltd.
2022.06 - Current
Study Start-Up Specialist
BeiGene, Ltd.
2020.04 - 2022.06
Clinical Research Coordinator
Guangzhou Medsi Medical Technology Co., LTD
2018.09 - 2020.04
CET-6
2016-03
Bachelor of Science - Pharmaceutical Engineering
Wuhan University of Bioengineering
2014.09 - 2018.09