Mô tả công việc
The Oxford University Clinical Research Unit (OUCRU) is a large- scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU Nepal has partnerships with the Patan Academy of Health Sciences and Patan Hospital, and OUCRU Indonesia exists in partnership with the University of Indonesia. As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.
Reporting to
JDHAN- 0425- 005
Clinical Trials Unit
OUCRU- VN offices at the National Hospital for Tropical Diseases, Kim Chung, Dong Anh and at the National Institute of Hygiene and Epidemiology in Hanoi. Travel to hospitals, units around Hanoi, or within Viet Nam might be required.
Please see more information on OUCRU website: www.oucru.org
OUCRU’s vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care.
Initially for 01 year, including a 02- month probation period, with possibility of extension.
Vacancy reference
Full time: Monday – Friday, 37.5 hours per week, extra hours may be required.
CTU Manager
Group
Key responsibilities and tasks
Location
The role of the Project Manager is overall managing the project in the study countries across Asia and Africa to ensure the project is delivered on time with the adherence to study protocol, GCP and local requirements.
A highly motivated Coordinator is required to work with in our clinical trials unit (CTU) to work with OUCRU’s Principle Investigators (PIs) and local partners to coordinate and manage the implementation of OUCRU research projects across Vietnam, including both clinical and community- based studies; to ensure efficient and high quality research operations in line with international standards; to contribute to the continued growth and development of OUCRU’s research portfolio in Vietnam
OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
Tenure
Job summary
Background
Hours of work
· Coordinate patient visit schedule in clinical studies as per study protocol where appropriate.
· Translate study documents (Vietnamese- English – Vietnamese) if appropriate.
· Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
· Participate in study team meetings to share experience and contribute to the knowledge of others in the team.
· Attend career training to improve skills and update relevant knowledge.
· Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.
· 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
· 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
· Organize, 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.
· Track study progress and identify problems. Report to stakeholders as required and work with PI’s and local partner(s) to find solutions
· 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
· Supervise the transfer of documents to the central OUCRU file server.
· 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
· Develop standard operating procedures to control the quality of study implementation
· Other tasks as required.
Selection criteria
Essential:
· 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
· Excellent Vietnamese language skills
· Public health, Pharmacy, Nurse, Medicine or Life Science
· 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
Desired:
· Master degree in clinical studies, epidemiology and public health or related fields
· 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
· Experience in budgeting, monitoring budget and managing procurement
· Experience in conducting clinical research in both hospital and community settings
Benefits
- Contracted salary:
- Salary ranges: $1,042- $1,147 gross per month
- Other responsibilities and
- Two months’ salary for annual bonus and clothes
- Annual leave 18 days each year for the first year
- Grade: RS3/IC3
- Optional insurance: In- patient and out- patient medical coverage; Personal accident insurance coverage
