Vacancy Announcement Clinical Trial Pharmacist OUCRU Nepal

Oxford University Clinical Research Unit-Nepal (OUCRU-NP) announces vacancy for Clinical Trial Pharmacist

Job Description

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit with site offices in Viet Nam, Indonesia, and Nepal.

Part of the Centre for Tropical Medicine and Global Health at the University of Oxford (UK), OUCRU was first established in Ho Chi Minh City in 1991, hosted by the Hospital for Tropical Diseases (HTD), Viet Nam. In 2003, OUCRU-NP was established in Kathmandu, Nepal, hosted by Patan Hospital and the Patan Academy of Health Sciences. OUCRU Hanoi was established in 2006 in partnership with the National Hospital of Tropical Diseases (NHTD), Viet Nam. In 2008, the Eijkman-Oxford Clinical Research Unit (EOCRU) was established in Jakarta, Indonesia, in partnership with the Eijkman Institute for Molecular Biology and Faculty of Medicine University of Indonesia.

Our vision is to have a local, regional and global impact on health by leading a locally-driven research programme on infectious diseases in Southeast Asia.

Our research programme covers clinical and laboratory research with hospital and community-based patient populations, including epidemiology, immunology, host and pathogen genetics, molecular biology, microbiology and virology, mathematical modelling, bioinformatics, biostatistics, and social science. This work is supported by an extensive clinical trials unit and data management centre compliant with national and international regulations and comprehensive management, finance, public engagement, and administrative support offices.

OUCRU receives considerable support from Wellcome Trust as part of the Africa and Asia Programmes. Together with our partners, we have led a highly successful effort in enhancing the infrastructure and capacity to perform clinical trials and basic scientific research in Viet Nam, Indonesia, and Nepal.

Position: Clinical Trial Pharmacist

The Clinical Trial Pharmacist will be responsible for managing the Investigational Medicinal products (IMPs) for clinical trials at OUCRU Nepal.

Key responsibilities:

Coordinate and manage procurement, storage, packaging, dispensing and accountability of IMPs according to protocol requirements
Coordinate and communicate with the regulatory authorities regarding the approvals and licensing of the clinical trial
Work closely with the research team to implement and maintain adherence to the trial protocol
Communicate with, and train staff anticipated to participate in any aspect of the clinical investigational drug trial.
Contribute to the development of Standard Operating Procedures (SOPs) and logs related to IMP management including drug dispensing, accountability, temperature maintenance etc.
Coordinate with the trial coordinator and the sponsor to ensure all the documents are in place which are required for submission to the regulatory authorities
Maintain a pharmacy binder which contains documents of IMP such as Summary of Product Characteristic (SmPC), protocol, Good Manufacturing Practice (GMP), Certificate of Analysis (COA) etc.
Maintain accurate and comprehensive records of drug accountability, dispensing, and patient interactions in accordance with trial protocols Collaborate with multidisciplinary teams, including trial coordinators, monitors, hospital study team, to optimize patient care and study outcomes.
Maintain responsibility for the management of the inventory for clinical investigational drug trials; order, replace and return study materials, as required.
Communicate effectively with study sponsors and regulatory authorities as required Stay updated on regulations and best practices to contribute to the continuous improvement of pharmacy services within the clinical trial setting.
Carry out other duties as required by the project.

Qualifications

Essential criteria:
– Doctor of Pharmacy (PharmD) degree.
– Prior experience in working in clinical trial.
– Excellent communication and interpersonal skills.
– Detail-oriented with strong organizational abilities.
– Ability to work independently and collaboratively in a team.
Preferred criteria
– Master degree in pharmacy
– Strong understanding of GCP and GMP guidelines.

If you meet the criteria, or know anybody who might be interested, please share your resume to : hr@oucru.org or sprajapati@oucru.org
Apply Before : January 14, 2024