Clinical Research Monitor (Jdhan_0224_002)

Mô tả Công việc
Please see more information on OUCRU website: www.oucru.org
CTU Manager
Clinical Trials Unit (CTU)
JDHAN_0224_002
This post is based in Ha Noi, with some travel required.
Group
Reporting to
Location
OUCRU&039;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.
Initially for 01 year, including a 02- month probation period, with possibility of extension based on annual performance appraisal
Background
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.
Full time: Monday- Friday, 37.5 hours per week, extra hours may be required
The 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.
Vacancy reference
Job summary
Hours of work
OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
Tenure

Yêu Cầu Công Việc
Key responsibilities and tasks
The 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):
Ø Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
Ø Confirm that the site has adequate qualifications and resources to start the study
Ø Verify the reporting of safety events and protocol non- compliance
Ø Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
Ø Write monitoring reports to summarize findings at a site
Ø Meet with study staff to explain findings and support staff to correct non- compliance
Ø Verify investigational product records and inventory
Ø Verify that each participant or their representative has given informed consent to participate in the study
Ø Confirm accuracy and completeness of source documents and CRFs
Ø Verify participant eligibility
Ø Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted
· Attend career training to improve skills and update relevant knowledge
· Support to review study SOPs at the set- up phase
· Help to maintain the clinical trials unit quality assurance systems.
· Translate study documents (Vietnamese- English- Vietnamese)
· Maintain an up- to- date understanding of clinical research conducted by OUCRU- VN
· Other tasks as required
Selection criteria
Essential:
· Willing to travel within Viet Nam and abroad.
· Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.
· Proven oral and written presentation skills.
· Excellent diplomatic communication and interpersonal 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
· Experience in conduct, coordinating, monitoring or quality assuring of clinical research
· Excellent Vietnamese and English language skills.
· High level of organizational and record keeping skills.
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,[protected info] gross per month
- Annual leave 18 days/year for the first year, a maximum of 30 days
- Optional insurance: In- patient and out- patient medical coverage; Personal accident insurance coverage
- Other responsibilities and benefits are based on Viet Nam Labor Law.
- Two months salary for annual bonus and clothes
How to apply
Interested 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:
* 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 person
Pham Thi Thanh Hoa
Deadline for submission
6 March 2024

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Cập nhật gần nhất lúc: 2024-04-03 12:05:58