Dien Linh Tran
Clinical Trial Officer at Woolcock Institute of Medical Research- Claim this Profile
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Bio
Credentials
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Writing in the Sciences
CourseraFeb, 2023- Sep, 2024 -
DAIDS Clinical Trials Networks Pharmacy Guidelines Training
National Institute of Allergy and Infectious Diseases (NIAID)Dec, 2022- Sep, 2024 -
DAIDS Human Subjects Protection/Good Clinical Practice (HSP/GCP)
National Institute of Allergy and Infectious Diseases (NIAID)Dec, 2022- Sep, 2024 -
Data Management for Clinical Research
CourseraNov, 2022- Sep, 2024 -
Medidata Rave EDC: Clinical Research Coordinators
Medidata AcademyJul, 2022- Sep, 2024 -
TOEIC 935
ETSJan, 2022- Sep, 2024 -
TOEFL Reading and Listening Sections Skills Mastery
CourseraSep, 2021- Sep, 2024 -
IELTS 7.0
British CouncilAug, 2015- Sep, 2024 -
GOOD CLINICAL PRACTICE - GCP
NIDA Clinical Trials NetworkJan, 2022- Sep, 2024
Experience
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Woolcock Institute of Medical Research
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Australia
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Research
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100 - 200 Employee
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Clinical Trial Officer
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Jan 2022 - Present
- Assists in the evaluation of study-related materials, creates and translates Protocols, SOPs, CRFs (English - Vietnamese - English)- Organizes, arranges and maintains source documents and regulatory documentation of clinical trials including Trial Master File (Investigation Site File) and Pharmacy Master/Site Binder for sites.- Tracks study progress and identify problems. Report to stakeholders as required. Supports study sites in reviewing study contracts to accelerate the contract signing progress.- Plans, implements, and coordinates all aspects of data collection, recording, and source documentation, as per ICH-GCP guidelines.- Executes study-related administrative tasks, such as the collection of data and regulatory documents, managing reimbursement for patients and study staff, filing, or retrieving files, maintaining patient charts, and supply inventories. - Substantial experience using computerized information systems (MS Office) and Electronic Data Capture systems and other CTMS as applicable. Verifies that data entered into CRFs is complete and consistent with patient clinical notes, known as source data/document verification.- Training, oversight and case management: Monitors health and safety of subjects with frequent contact and ensure subject compliance with the study protocol.- Prepares training materials and delivers presentations on protocol-relevant procedures for local HCW at study sites including those for laboratory samples, study medication, and patient assessment.- Good clinical practice compliance: Supervises the conduct of the study to ensure compliance with the principles of Good Clinical Practice, which will involve visiting the study sites on a regular basis. Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Clinical Research Monitoring Plan. Show less
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Study Pharmacist
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Jan 2022 - Present
- Manages study products, performs particular management actions regarding study investigational products, drug accountability, inventory, reconciles, and reviews storage and security requirements. - Develops Pharmacy Establishment Plan for assigned clinical research sites and strengthens key relationships with collaborative healthcare workers at the pharmacy.- Supports local healthcare workers in recruitment, clinical assessment, and reporting.
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University of Medicine and Pharmacy, Ho Chi Minh City
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Vietnam
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Higher Education
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100 - 200 Employee
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Research Assistant of Pharmacoeconomic Laboratory
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Jan 2018 - Dec 2021
- Collaborated on some studies in the Pharmacoeconomic field regarding both Systematic review and Cost-effectiveness analysis alongside Clinical Trials research. - Provided leadership, oversight, and time-management expertise to cooperate with a team of 4 undergraduate pharmacy students working on research and supported them in their research process. - Collaborated on some studies in the Pharmacoeconomic field regarding both Systematic review and Cost-effectiveness analysis alongside Clinical Trials research. - Provided leadership, oversight, and time-management expertise to cooperate with a team of 4 undergraduate pharmacy students working on research and supported them in their research process.
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Korea United Pharm
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Pharmaceutical Industry Intern
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Mar 2021 - Mar 2021
Pharmaceutical Industry: - How to arrange production models and production processes for non-penicillin drugs and dietary supplement - Operating machines to produce many different dosage forms: powder drug, capsule, tablet, soft capsule, different blisters... - Process of operating and managing store of materials and pharmaceuticals - Drug Quality Control, QC, QA Pharmaceutical Industry: - How to arrange production models and production processes for non-penicillin drugs and dietary supplement - Operating machines to produce many different dosage forms: powder drug, capsule, tablet, soft capsule, different blisters... - Process of operating and managing store of materials and pharmaceuticals - Drug Quality Control, QC, QA
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Clinical Pharmacy Intern
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Jan 2021 - Feb 2021
Clinical Pharmacist, Pharmacy Consultant: - Check outpatient prescriptions - Support in making clinical recommendations regarding medication safety issues (drug interactions, ADR, antibiotic approval) Clinical Pharmacist, Pharmacy Consultant: - Check outpatient prescriptions - Support in making clinical recommendations regarding medication safety issues (drug interactions, ADR, antibiotic approval)
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Consultant Pharmacist
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Sep 2020 - Sep 2020
- Support distribution of study drugs in pharmacy - Learn and obtain knowledge regarding on-sale products in the pharmacy - Support distribution of study drugs in pharmacy - Learn and obtain knowledge regarding on-sale products in the pharmacy
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Education
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2016 - 2021
University of Medicine and Pharmacy, Ho Chi Minh City
Bachelor of Pharmacy - BPharm, Pharmacoeconomics/Pharmaceutical Economics
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