Clinical Research Monitor (JD-0124-003)

JOB SUMMARY

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified quality assurance officer to ensure efficient and high quality research operations in line with international standards. The Monitor will perform clinical trials monitoring in compliance with the guidelines of Good Clinical Practice from the International Conference on Harmonization, the Medical Research Council-UK, the Viet Nam Ministry of Health or other local regulatory authorities in addition to developing and maintaining quality assurance systems in study processes including laboratory, data management and drug management processes. The post holder will contribute to the continued growth and development of the CTU team and collaborating research units internationally.

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KEY TASKS & RESPONSIBILITIES

The post holder will report to the OUCRU-VN Head of CTU/ Vice Head of CTU/ Monitor Team Leader and will be responsible for (but is not limited to) the following tasks:

· Implement the monitoring plan by arranging visits with the study site based on study progress.

· Work with study coordinator to conduct monitoring visits to verify compliance of study conduct with the required guidelines and study plans including (but not limit to):

Ø Confirm that the site has adequate qualifications and resources to start the study

Ø Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted

Ø Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents

Ø Verify that each participant or their representative has given informed consent to participate in the study

Ø Verify participant eligibility

Ø Confirm accuracy and completeness of source documents and CRFs

Ø Verify the reporting of safety events and protocol non-compliance

Ø Verify investigational product records and inventory

Ø Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures

Ø Meet with study staff to explain findings and support staff to correct non-compliance

Ø Write monitoring reports to summarize findings at a site

· Help to maintain the clinical trials unit quality assurance systems.

· Support to review study SOPs at the set-up

· Maintain an up-to-date understanding of trials conducted by OUCRU-VN.

· Attend career training to improve skills and update relevant knowledge.

· Translate study documents (Vietnamese - English – Vietnamese)

· Other tasks as required.

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GROUP

Clinical Trials Unit (CTU)

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

Head of CTU/ Vice Head of CTU/ Monitor Team Leader