Khanh Nguyen

Experience

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  Vietnam Institute of Applied Medicine

  Nov 2015 - Aug 2016

  Translator and project manager

  - Translating materials of nutrition and healthcare for the Institute’s website. - Doing projects about nutrition and medicine for partner companies: preparing scientific documents of the company's products, writing scientific articles for company's products

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  Family Medical Practice Vietnam

  Sept 2016 - Feb 2017

  Pharmacist

  • Advise physicians and other health practitioners on the selection, dosages, interactions and side effects of medications.• Advise patients and answer their questions about side effects and drug interactions.• Provide information and make recommendations about over-the-counter drugs.• Dispensing prescription medicines to the patients.• Checking dosage and ensuring that medicines are correctly and safely supplied and labelled (pharmacists are legally responsible for any dispensing errors).• Liaising with doctors about prescriptions.• Keeping up to date with current pharmacy practice, new drugs and their uses. Show less

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  Otsuka Pharmaceutical Co., Ltd.

  Mar 2017 - Oct 2017

  Regulatory Affairs & Quality Assurance

  Main responsibilities:- Prepare, submit and follow up the registration of therapeutic drugs.- Cooperate with relevant departments (marketing, sales) to prepare and submit the productsbrochure.

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  Janssen Inc.

  Nov 2017 - Jun 2020

  Regulatory Affairs Specialist

  REGULATORY PROFESSIONAL - SUBMISSION SPECIALIST- Creating submissions with a high level of quality within the Asia Pacific Regulatory Management Center in a timely manner and maintaining compliance of approved documents and related global databases.- Responsible for connecting with Global, Regional and Local RA colleagues on local dossier requirements from global dispatch to local submission/approval.SYSTEM SPECIALIST- Creation of work folders in system when countries are impacted by labeling or CMC submissions- Regular maintenance of folders in systems and archived content- SPS: Responsible for set-up of local records and continuous update throughout submission and approval process and ensure 2nd verification- TrackWise: Responsible for set-up of local records and continuous update throughout submission and approval process- Generate reports and perform regular quality checks (QPPV) for tracking systems- Assist with ensuring LOC’s labeling compliance Show less

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  Oxford University Clinical Research Unit

  Jul 2020 - now

  Clinical Research Coordinator

  - Work with PI’s and local partner research institutions and hospitals to finalize research protocols, budgets, and other required documents project start-up phase- Support PI’s and local partners to prepare, submit and get ethical approval from local IRB committee(s) and/or other relevant international EC boards- Develop standard operating procedures to control the quality of study implementation- Organize logistics of study materials, including consumables, other studies’ materials and documents- Closely supervise the implementation of the studies to ensure efficient and high quality research operation in line with international standards, including principles of Good Clinical Practice- Track study progress and identify problems. Report to stakeholders as required and work with PI’s and local partner(s) to find solutions- Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.- Plan, implement and coordinate all aspects of data collection and entering management and cleaning, and storage, following OUCRU’s data management policy and ICH GCP guidelines if appropriate- Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files, maintaining patient charts and supply inventories with clinical trials.- Translate study documents (Vietnamese - English – Vietnamese) - Supervise the transfer of documents to the central OUCRU file server.- Coordinate patient visit schedule in clinical studies as per study protocol where appropriate.Organise, plan and co-ordinate ICH GCP training for local study staff in Hanoi and the region whenever needed.- Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment wherever it is appropriate. Show less