Clinical Specialist ★ 4.2

Mô tả Công việc

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.

***

KEY TASKS & RESPONSIBILITIES

- 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

(a) verify that all analytical and sample processing procedures are being carried out accurately

(b) Confirm that all processes are subject to adequate quality control

(c) Ensure the most recent version of the Protocol and Lab Manuals are being used

(d) Verify that action items have been adequately documented, addressed, and resolved.

(e) 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

***

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