Group
CTU
Location
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.
Hours of work
Full time: Monday – Friday, 37.5 hours per week, extra hours may be required.
Tenure
Initially for 01 years, including a 02 month probation period, with possibility of extension based on annual performance appraisal and Research approval
Reporting to
Manager of Hanoi CTU
Vacancy reference
JDHAN- 1124- 010
Background
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.
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.
Job summary
- 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
· 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
· 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
· Translate study documents (Vietnamese- English – Vietnamese) if appropriate.
· Participate in study team meetings to share experience and contribute to the knowledge of others in the team.
· 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.
·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.
· Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.
· 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
· 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.
· 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
· 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.
· Other tasks as required.
· Attend career training to improve skills and update relevant knowledge.
· 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
· 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
· Liaise and work with study team to develop study plans, study procedures, study documents
