Manager / Head of Hanoi Clinical Trials Unit
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.
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
- Medical doctor or Master’s degree in a health-related science with at least 3 years of relevant experience conducting or managing clinical trials.
- Excellent Vietnamese and very good English language skills
- 2-4 years of people management experience
- Good understanding of Good Clinical Practice guidelines in clinical research
- Excellent skills in oral and written communication
- Ability to work closely with other study staff, hospital and public health/government collaborators
- Good attention to detail in following protocols and keeping records
- Interest in clinical and/or epidemiological research
- Willing to travel within country and abroad
- Experience in working in an international environment
- Experience in liaising with Ministries and/or other national bodies
- Understanding of academic, research or not-for-profit working environment
- Able to work with a minimum of supervision