Key responsibilities and tasks
· Participate in study team meetings to share experience and contribute to the knowledge of others in the team.
· Coordinate patient visit schedule in clinical studies as per study protocol where appropriate.
· Organize, plan and co- ordinate ICH GCP training for local study staff in Hanoi and the region whenever needed.
· Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.
· 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.
· Organize logistics of study materials, including consumables, other studies’ materials and documents
· Track study progress and identify problems. Report to stakeholders as required and work with PI’s and local partner(s) to find solutions
· Supervise the transfer of documents to the central OUCRU file server.
· Develop standard operating procedures to control the quality of study implementation
· Attend career training to improve skills and update relevant knowledge.
· Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
· 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
· Translate study documents (Vietnamese- English – Vietnamese) if appropriate.
· Work with PI’s and local partner research institutions and hospitals to finalize research protocols, budgets, and other required documents project start- up phase
· 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
· 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
· 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.
· Other tasks as required.
Selection criteria
Essential:
· Excellent Vietnamese language skills
· Advanced level of English comprehension, including the ability to do translations from English to Vietnamese and vice versa
· Excellent interpersonal communication/diplomatic skills with people of different backgrounds and social positions
· Public health, Pharmacy, Nurse, Medicine or Life Science
· Good understanding of general ethical considerations applicable to research and good clinical practice (GCP) guidelines and other relevant regulations in conducting studies, including clinical trials
Desired:
· Experience in conducting clinical research in both hospital and community settings
· Master degree in clinical studies, epidemiology and public health or related fields
· Experience in budgeting, monitoring budget and managing procurement
· Experience of working in a research institution with involvement in research protocol and data collection tools development and IRB submission Experience of monitoring/managing research/studies, including both clinical trials/research and community- based studies
Benefits
- Contracted salary:
- Salary ranges: $1,042- $1,147 gross per month
- Grade: RS3/IC3
- Two months’ salary for annual bonus and clothes
- Optional insurance: In- patient and out- patient medical coverage; Personal accident insurance coverage
- Annual leave 18 days each year for the first year
- Other responsibilities and benefits are based on Viet Nam Labour Law.
Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates by email to Ms. Pham Thi Thanh Hoa- Operations Manager.
How to apply
* The cover letter should detail:
- What part of your education, training or employment history has best equipped you for this position and why you would be a good candidate?
- Contacts of two referees who are your latest managers and can provide details of relevant work experience and attitude
* We thank all applicants for their interest but only short- listed candidates will be contacted for interview.
Deadline for submission
Pham Thi Thanh Hoa
30 April 2025
Contact person
