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 Verify that each participant or their representative has given informed consent to participate in the study
Ø Verify participant eligibility
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 Verify the reporting of safety events and protocol non- compliance
Ø Write monitoring reports to summarize findings at a site
Ø Confirm accuracy and completeness of source documents and CRFs
Ø Meet with study staff to explain findings and support staff to correct non- compliance
Ø Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
Ø Verify investigational product records and inventory
Ø Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
· Attend career training to improve skills and update relevant knowledge.
· Support to review study SOPs at the set- up
· Maintain an up- to- date understanding of trials conducted by OUCRU- VN.
· Other tasks as required.
· Help to maintain the clinical trials unit quality assurance systems.
· Translate study documents (Vietnamese- English – Vietnamese)
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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

ESSENTIAL CRITERIA
· Understanding of ICH- GCP guidelines, local and international regulations on clinical research.
· Willing to travel within Viet Nam and abroad.
· Proven oral and written presentation skills.
· Excellent diplomatic communication and interpersonal skills.
· Experience in conduct, coordinating, monitoring or quality assuring of clinical research
· High level of organizational and record keeping skills.
· Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.
· Excellent Vietnamese and English language skills.
· Self- starter, detail- oriented, good time management, problem solver, flexible and adaptable, self- confident
DESIRED CRITERIA
· Experience working as a clinical research monitor
· Scientific and/or clinical knowledge needed to monitor the trial adequately
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BENEFITS​
- Contracted salary:
Grade: RS3/IC3
Salary ranges: $ 1,092- $ 1,335 gross per month
- Other responsibilities and benefits are based on Viet Nam Labor Law.
- Optional insurance : In- patient and out- patient medical coverage; Personal accident insurance coverage
- Annual leave 18 days/year for the first year, a maximum of 30 days
- Two months salary for annual bonus and clothes
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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
Hospital for Tropical Diseases
Laboratory of Clinical Science
764 Vo Van Kiet, Ward 1, District 5, HCMC
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DEADLINE FOR SUBMISSION
28 January 2024
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* We thank all candidates for their interest, but only short- listed applicants will be notified for interview.

Chế độ bảo hiểm, Du Lịch, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Công tác phí, Nghỉ phép năm

Cập nhật gần nhất lúc: 2024-01-12 18:00:28