Clinical Research Monitor (JDHAN_0224_002)

PositionClinical Research Monitor (JDHAN_0224_002)
GroupClinical Trials Unit (CTU)
LocationThis post is based in Ha Noi, with some travel required.
Hours of workFull time: Monday – Friday, 37.5 hours per week, extra hours may be required
TenureInitially for 01 year, including a 02-month probation period, with possibility of extension based on annual performance appraisal
Reporting toCTU Manager
Vacancy referenceJDHAN_0224_002
BackgroundThe 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
Job summaryThe 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.
Key responsibilities and tasksThe post holder will report to the OUCRU-HN CTU Manager 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):
+ Confirm that the site has adequate qualifications and resources to start the study
+ Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted
+ Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
+ Verify that each participant or their representative has given informed consent to participate in the study
+ Verify participant eligibility
+ Confirm accuracy and completeness of source documents and CRFs
+ Verify the reporting of safety events and protocol non-compliance
+ Verify investigational product records and inventory
+ Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
+ Meet with study staff to explain findings and support staff to correct non-compliance
+ 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 phase
– Maintain an up-to-date understanding of clinical research conducted by OUCRU-VN 
– Attend career training to improve skills and update relevant knowledge
– Translate study documents (Vietnamese – English – Vietnamese)
– Other tasks as required
Selection criteriaEssential

– Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.
– Experience in conduct, coordinating, monitoring or quality assuring of clinical research
– Proven oral and written presentation skills.
– Excellent diplomatic communication and interpersonal skills.
– High level of organizational and record keeping skills.
– Excellent Vietnamese and English language skills.
– Understanding of ICH-GCP guidelines, local and international regulations on clinical research.
– Self-starter, detail-oriented, good time management, problem solver, flexible and adaptable, self-confident
– Willing to travel within Viet Nam and abroad.

Desired

– Experience working as a clinical research monitor
– Scientific and/or clinical knowledge needed to monitor the clinical research adequately
Benefits– Contracted salary:
+ Grade: RS3/IC3
+ Salary ranges: $ 1,092 – $ 1,335 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 applyInterested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates by email to Ms. Pham Thi Thanh Hoa – Operations Manager: hoaptt@oucru.org

* The cover letter should detail:
– What part of your education, training or employment history has best equipped you for this position and why you would be a good candidate?
– Contacts of two referees who are your latest HR/ line manager and can provide details of relevant work experience and attitude

*** We thank all applicants for their interest but only short-listed candidates will be contacted for interview.
Contact personMs. Pham Thi Thanh Hoa
Deadline for submission29 March 2024
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