Trang Do Kieu
Hanoi,HN
Summary
Accomplished Clinical Research Associate with 7 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate
Oursourcing to George Clinical and Syneos Health
06.2023 - Current
- Set up and disbanded trial study centers to manage clinical study activities for [Number] sites
- Hired and trained over [Number] research subjects and monitored progress, answered questions and provided guidance during course of clinical study
Clinical Research Associate
Oursourcing to Parexel International
04.2022 - 09.2023
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Set up and disbanded trial study centers to manage clinical study activities for [Number] sites
Senior Clinical Research Associate
Vietstar Biomedical Research
06.2021 - 06.2022
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
Clinical Research Associate
Oursoucing to Syneos Health
04.2019 - 05.2021
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Clinical Resarch Associate
Vietstar Biomedical Research
04.2018 - 04.2019
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
Clinical Research Associate
Vietsstar Biomedical Research
03.2017 - 03.2018
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed informed consent processes and maintained records.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Hired and trained over [Number] research subjects and monitored progress, answered questions and provided guidance during course of clinical study
Education
Master of Science - Public Health
Hanoi School of Public Health
Hanoi09.2017
Bachelor of Science - Public Health
Hanoi School of Public Health
Hanoi, Vietnam05.2015
Skills
- Quality Control
- Recruitment Strategies
- Interdepartmental Collaboration
- Team Training
- Report Writing
- Completing regulatory documents
- Site Management
Accomplishments
- Resolved product issue through consumer testing.
- Collaborated with team of [Number] in the development of [Project name].
- Supervised team of [Number] staff members.
Timeline
Clinical Research Associate
Oursourcing to George Clinical and Syneos Health
06.2023 - Current
Clinical Research Associate
Oursourcing to Parexel International
04.2022 - 09.2023
Senior Clinical Research Associate
Vietstar Biomedical Research
06.2021 - 06.2022
Clinical Research Associate
Oursoucing to Syneos Health
04.2019 - 05.2021
Clinical Resarch Associate
Vietstar Biomedical Research
04.2018 - 04.2019
Clinical Research Associate
Vietsstar Biomedical Research
03.2017 - 03.2018
Master of Science - Public Health
Hanoi School of Public Health
Bachelor of Science - Public Health
Hanoi School of Public Health
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