|Laboratory Quality Monitor (for TB clinical trials)
|This post is based in Ho Chi Minh City, with some travel required.
|Hours of work
|37.5 hours per week, extra hours may be required.
|Initially for 01 year, including a 02 month probation period, with possibility of extension.
|Kennedy Awuondo, Head of Lab Management Group
|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.
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.
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
|The successful candidate’s responsibilities will be to monitor trial site laboratories in Ho Chi Minh City, Hanoi, and up to two sites in the Philippines for the PARADIGM4TB phase 2b clinical trial into new drugs and new drug regimens for the treatment of tuberculosis. The aim is to maintain Good Clinical Practice and Good Clinical Laboratory Practice. The post will be based within OUCRU’s Laboratory Management group but the candidate will trained and activities overseen by the clinical trial sponsor at University College London, UK.
|Key responsibilities and tasks
|– Monitor trial site laboratories (including TB laboratories) in line with requirements stipulated in the GCP- and GCLP Guidelines,
– Ensure familiarity with SOPs, trial Protocol, Lab Manual, QC Manual, SOPs, and regulatory requirements, and that these are being followed
– Monitoring site visits to verify that all analytical and sample processing procedures are being carried out accurately
– Confirm that all processes are subject to adequate quality control
– Ensure the most recent version of the Protocol and Lab Manuals are being used
– Verify that action items have been adequately documented, addressed, and resolved.
– Identify training needs and provide the relevant training/training materials
– Generate reports for the sponsor to summarise site visits, and follow-up
– Liaise closely with central laboratory monitoring team at UCL throughout
– More than 2 years’ work experience in a Mycobacteriology laboratory (BSL3), preferably in a senior position.
– Good knowledge of modern methods for detecting/isolating/characterizing M.tb – – Mycobacteria Growth Indicator Tube (MGIT) culture, Hain tests, etc.
– Experience with GCLP processes and requirements.
– Experience with QC/QA procedures and the writing of SOPs/Risk Assessments.
– Excellent written and verbal communication skills in English.
– Experience with lab assessments and capacity building towards accreditation.
|– Contracted salary:
Salary ranges: 1,626 – 1,802 USD gross per month
– Optional insurance : In-patient and out-patient medical coverage; Personal accident insurance coverage
– Two months salary for annual bonus and clothes
– Annual leave 18 days/year for the first year, a maximum of 30 days
– Other responsibilities and benefits are based on Viet Nam Labor Law.
|How to apply
|Interested candidates are invited to send curriculum vitae, application and copies of relevant certificates, either by email or by post to:
Oxford University Clinical Research Unit
Laboratory of Clinical Science
Hospital for Tropical Diseases
764 Vo Van Kiet, Ward 1, District 5, HCMC
*** We thank all candidates for their interest but only short-listed applicants will be notified for interview.
|Ms Nguyen Thi Hong Phuc
|Deadline for submission
|5 February 2024