Department
CTU
Location
OUCRU Hanoi
Hours of work
Full time Monday – Friday, 37.5 hours per week, extra hours may be required.
Tenure
Initially for 1 year, including a 2-month probation period, with possibility of extension based on annual performance appraisal and research approval.
Reporting to
Director OUCRU Hanoi
Vacancy reference
JDHAN_0621_009
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) and National Institute of Hygiene and Epidemiology in Hanoi. As a Wellcome Trust Africa Asia Programme, OUCRU have received considerable support from the Wellcome Trust since our establishment in 1991.
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 throughout Southeast Asia.
OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
Please see more information on OUCRU website: www.oucru.org
Job summary
The ongoing expansion and growth in research at OUCRU Hanoi has led to the requirement of new positions, including positions of leadership within our research team.
We are recruiting to the post of Manager / Head of OUCRU Hanoi Clinical Trials Unit to meet the challenge of this expansion and to execute and support new and ongoing research projects, including multi-site randomized controlled trials, large scale observational studies in hospital and community and the development of national services in collaboration with national bodies, including an antimicrobial resistance reference laboratory and serum bank. The post-holder will play a key role in all aspects of research governance and support.
The post-holder will lead a team of coordinators providing support to principal investigators during preparation for and implementation of studies and projects. This support includes the development and review of standard operating procedures (SOP) and logistical, data management and study monitoring plans, development and review of study protocol, informed consent forms (ICF) and case record forms (CRF), preparation and presentation of applications to ethical committees and regulators, control and management of regulatory documents, preparation of project agreements and contracts with partners (work with OUCRU Hanoi admin & finance team), coordination of patient recruitment and data/sample collection, CRF completion and data entry, study monitoring including participating in DSMB meetings, data management and governance (work with IT teams and data scientists in OUCRU Hanoi and HCMc), and ensuring correct Vietnamese translations.
Key responsibilities and tasks
The post-holder must be pro-active and ensure the work is of high standard. The selected candidate is expected to
· Supervise, guide, and advise a growing team of clinical research coordinators and administrators.
· Supervise other non-CTU staff responsible for coordinating and monitoring OUCRU studies.
· Support processes of regulatory compliance and response to operational issues.
· Ensure research studies are performed with integrity and high standard by providing optimal staffing and collaborating with the clinical and non-clinical support services departments.
· Ensure compliance to clinical research best practices, all applicable federal, state, and institutional regulatory guidelines.
· Perform assessments and evaluations to determine needs and best approaches to implementation of new processes, protocols, and procedures.
· Facilitate and ensure cross-functional resource support for projects.
· Work with OUCRU Hanoi Admin and Finance in the development of project agreement and other research related contracts.
· Work with OUCRU Hanoi Admin and Finance, researchers and collaborators to solve all issues related to study budgets and payments.
· Maintain an up-to-date understanding of the applicable trial regulations, both local and international, transfer to investigators on regulatory changes and ensure that these standards are implemented in all OUCRU HN research.
· Lead or support execution of new research projects as project coordinator
· Ensure and maintain consistency with OUCRU programme-wide procedures regarding study operations and governance by frequent liaising with OUCRU-HCMC.
· Act as focal point in liaison with regulators, ethical committees and CTU OUCRU-HCMC to ensure optimal communications between OUCRU and these bodies.
· Build relationships and maintain good and frequent communication with collaborating staff at study sites, to ensure participants’ well-being, compliance with study protocols and quality of clinical data.
· Build and maintain relationships with points-of-contact / leadership at study sites and act as a liaison between OUCRU Hanoi and the site.
· Develop and retain research staff providing them an environment that fosters professional development through continuous learning.
· Other tasks as required