Allen Teng

Experience

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  Protech Pharmaservices Corporation

  Sept 2016 - Apr 2018

  Clinical Research Coordinator

  -Accomplished dozens of generic drug studies, including valsartan, amlodipine, tadalafil, lansoprazole, loratadine, etoricoxib, budesonide, and fumarate, etc.-Conducting phase-I & III studies, which the drug indication includes community-acquired pneumonia and erectile dysfunction.-Responsible for IRB, TFDA, and FDA inspection to prepare all related documents that includes ISF, source documents, case report forms, and the main respondent in the audit.-As a mentor to train new members of operation skills, regulation and GCP knowledge. Show less

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  Zhejiang Hui-Zhe Medical Technology Co. Ltd

  May 2018 - Feb 2020

  Clinical service assistant manager

  -Creating SOP of phase-I center, including trial execution, instruments and pharmacy procedures.-Introducing a timely data collection system, Trial-One (EDC), to decrease human resource 30% to 40%.-Enhancing working independently ability and quality to 50% among 10 above core team members via training programs and created demonstration videos.-In charge of all kinds of audits, including NMPA, IRB, sponsors and third party.-Being a consultant for protocol design and clinical operations. Show less

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  KGS Pharmamate Co., Ltd

  May 2021 - Apr 2022

  Clinical research coordinator in new drug and medical device

  -Experiences in IRB amendment and interim reports, SIV, trial execution, AE/SAE notification, EDC quality control and SCV.-Responsible for 1 phase-II and 2 phase-IV trials, totally enrolled and completed over 150 subjects.-In charge of IRB submission at TVPGH, TSGH and TMUH; submission for multiple amendments and interim reports; notification for multiple SAE initial and FU reports.-Time management accurately while facing assigned activities and occasional issues, changing priorities to achieve goals.-Familiar with EDC system, data analysis, query replying and study budget control. Show less

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  QPS Holdings, LLC

  May 2022 - now

  Clinical Research Associate

  -Conducting 6 projects simultaneously, and 3 oncology trial experiences included.-Experiences for 8 site selection, site initiation visit, and 4 to 6 times monitoring visit per month.-Over 15 interim reports submitted per year for over 10 sites.-IRB audit experience without major findings.-Routine site supporting and management for filing of ISF/TMF, PD/UC and SAE notification assisted, SC training and refreshing, and financial management.-Analyzing protocol issues and site’s difficulties to develop subject recruitment strategy.-Familiar with EDC system (OpenClinica) and assisting 5 sites to close over 500 queries within 2 weeks.-Cooperation with study team members to achieve the goal for all milestones. Show less