Research Pharmacy Coordinator; JDHCM

Position: Research Pharmacy Coordinator (Group Clinical Trial Unit (CTU))

Location: This post is based in Ho Chi Minh City, Viet Nam. Travel to hospitals or units around Ho Chi Minh City will be required regularly. Travel within Vietnam or internationally will be required.

Hours of work: Full‑time

Tenure: 1‑year contract position, including 2‑month probation, with possibility of extension.

Reporting to: Pharmacy Team Leader

Vacancy reference: JDHCM-

Background: The Oxford University Clinical Research Unit (OUCRU) is a large‑scale clinical and public health research unit, with sites 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 closely collaborates with the National Academy of Medical Sciences in Kathmandu, 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. 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. Please see more information on OUCRU website:(Use the "Apply for this Job" box below)..org

The Research Pharmacy coordinator is responsible for managing all investigational products used in OUCRU‑VN clinical research. The coordinator will perform duties associated with dispensing and control of investigational products, ensuring standard operating procedures provide quality pharmaceutical practice for studies in Vietnam’s most significant infectious diseases. The coordinator will oversee satellite clinical research pharmacies, train pharmacy and study staff in procedures of maintaining a clinical research pharmacy, and manage pharmacy storage.

Duties:

Key duties/tasks:

• Safeguard research participants, patients and researchers by ensuring that study drugs of United4tb study are appropriate for use and are procured, handled, stored and used safely and correctly in accordance with the study protocol.
• Manage the OUCRU Clinical Research Pharmacy including a fully documented study drug management system.
• Develop study pharmacy management standard operating procedures for the United4tb study.
• Order, stock, and manage the inventory of study drugs according to Study SOPs at OUCRU storage & study sites.
• Design study drug kit of United4tb study in accordance with the study protocol, plan and prepare patient treatment kits, manage logistics and documentation from suppliers and external sites.
• Arrange for transfer and shipping of study drug kit of United4tb study to study sites as required.
• Conduct monitoring visits of United4tb study related to study drugs at the study sites.
• Process the regulatory permissions necessary to import and use new products for United4tb study.
• Maintain an up‑to‑date understanding of local and international pharmaceutical and clinical trial regulations, ensuring that all pharmacy procedures comply with relevant guidelines and regulations.
• Source suppliers of drugs and formulations for clinical trials, follow up with the purchasing team to obtain medicines as required for studies.
• Coordinate with statisticians to prepare randomisation sequences, meeting the design requirements of the study protocol.
• Ensure that all data and documentation associated with a study are accurate, up‑to‑date and available for audit or inspection by an appropriate authority.
• Provide training for pharmacy staff at the site related to study drug management.
• Conduct the second inspection for other studies with activities related to the preparation of study drugs: labeling, creating drug kits, unblinding …
• Be available outside of working hours in urgent cases to…