Mô tả công việc
Group
CTU
Initially for 01 years, including a 02 month probation period, with possibility of extension based on annual performance appraisal and Research approval
Background
OUCRU- VN offices at the National Hospital for Tropical Diseases, Kim Chung, Dong Anh Hanoi, and at the National Institute of Hygiene and Epidemiology in Hanoi. Travel to hospitals, units around Hanoi, or within Viet Nam might be required.
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.
Full time: Monday – Friday, 37.5 hours per week, extra hours may be required.
Job summary
Please see more information on OUCRU website: www.oucru.org
Manager of Hanoi CTU
JDHAN- 1124- 010
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.
Vacancy reference
Tenure
Reporting to
Location
Hours of work
- 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
Key responsibilities and tasks
· Work with PI’s and local partners, research institutions and hospitals to finalize research protocols, budgets and project agreements/contracts (study- related information), and other required documents of the project
· Track study progress and identify problems. Report to stakeholders as required and work with PI’s and local partner(s) and the study team to find solutions
· Support PI’s and local partners to prepare, submit and get ethical, administrative and regulatory approval from relevant review boards such as local IRB committee(s) and/or other relevant international EC boards
· Other tasks as required.
· Liaise and work with study team to develop study plans, study procedures, study documents
·Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and study participant assessment wherever it is appropriate.
· 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
· Participate in study team meetings to share experience and contribute to the knowledge of others in the team.
· Translate study documents (Vietnamese- English – Vietnamese) if appropriate.
· Liaise with sponsor for monitoring/audits. Write, file and collate study documentation and visit reports with respect to monitoring.
· Supervise the transfer of documents to the central OUCRU file server.
· Plan, implement and coordinate all aspects of data collection activities, data entry, data 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, supporting partners in study- related information in financial and administrative documents, managing reimbursement for study activities, patients/participants and study staff, filing or retrieving all study files and ensure correct versions of approved study documents are being in use, maintaining patient/participant charts and supply inventories for the research studies.
· Organize logistics of study materials, including consumables, equipment, other studies’ materials and documents; work with OUCRU travel/admin/research team to coordinate the preparation and logistics of study meetings and group study trips
· Coordinate participant visit schedule in research studies as per study protocol where appropriate.
· Attend career training to improve skills and update relevant knowledge.
· Organize, plan and co- ordinate ICH GCP training for local study staff in Hanoi and the region whenever needed.
· Develop standard operating procedures to control the quality of study implementation
· Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.
Selection criteria
Essential:
·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
·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 and communication skills
·Public health, Pharmacy, Nurse
Desired:
·Experience in budgeting, monitoring budget and managing procurement
·Master degree in clinical studies, epidemiology and public health or related fields
·Experience in conducting antimicrobial stewardship and antimicrobial resistance research
· 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:
Grade: RS3/IC3
Salary ranges: 1042- 1147
- Annual leave 18 days/year for the first year, a maximum of 30 days
- Two months salary for annual bonus and clothes
- Other responsibilities and
- Optional insurance: In- patient and out- patient medical coverage; Personal accident insurance coverage
