Laboratory Quality Monitor (JD-0124-001)

JOB SUMMARY
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.
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KEY TASKS & RESPONSIBILITIES
- Monitoring site visits to
- 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
(d) Verify that action items have been adequately documented, addressed, and resolved.
(a) verify that all analytical and sample processing procedures are being carried out accurately
(c) Ensure the most recent version of the Protocol and Lab Manuals are being used
(e) Identify training needs and provide the relevant training/training materials
(b) Confirm that all processes are subject to adequate quality control
- Generate reports for the sponsor to summarise site visits, and follow- up
- Liaise closely with central laboratory monitoring team at UCL throughout
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DEPARTMENT
Lab Management
LOCATION
This post is based in Ho Chi Minh City, with some travel required.
HOURS OF WORK
Full time. 37.5 hours per week, extra hours may be required
TENURE
Initially for 1 year, including a 2- month probation period, with the possibility of extension.
REPORTING TO
Kennedy Awuondo, Head of Lab Management Group

ESSENTIAL CRITERIA
· Good knowledge of modern methods for detecting/isolating/characterizing M.tb – Mycobacteria Growth Indicator Tube (MGIT) culture, Hain tests, etc.
· More than 2 years’ work experience in a Mycobacteriology laboratory (BSL3), preferably in a senior position.
· Excellent written and verbal communication skills in English.
· Experience with QC/QA procedures and the writing of SOPs/Risk Assessments.
· Experience with GCLP processes and requirements.
DESIRED CRITERIA
· Experience with lab assessments and capacity building towards accreditation
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BENEFITS​
- Contracted salary:
Salary ranges: 1,626- 1,802 USD gross per month
Grade: RS4/IC4
- Two months salary for annual bonus and clothes
- Optional insurance: In- patient and out- patient medical coverage; Personal accident insurance coverage
- Other responsibilities and benefits are based on Viet Nam Labor Law.
- Annual leave 18 days/year for the first year, a maximum of 30 days
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HOW TO APPLY
Interested candidates are invited to send curriculum vitae, application, writing samples and copies of relevant certificates, by email to
Oxford University Clinical Research Unit
Laboratory of Clinical Science
764 Vo Van Kiet, Ward 1, District 5, HCMC
Hospital for Tropical Diseases
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DEADLINE FOR SUBMISSION
5 Feb 2024
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* We thank all candidates for their interest but only short- listed applicants will be notified for interview.

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Cập nhật gần nhất lúc: 2024-01-05 21:25:23