Job titleEthics and Regulatory SpecialistGroupClinical Research Management and Governance Group (CRMG-HCM)LocationThis post is based in Ho Chi Minh City.Hours of work37.5 hours per week, extra hours may be required.TenureInitially for 1-year contract, including a 2-month probation, with possibility of extension.Reporting toResearch Ethics and Regulatory ManagerVacancy referenceJDHCM-1126-021BackgroundThe 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 closely collaborates with the National Academy of Medical Sciences in Kathmandu, 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 key 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.

Please see more information on OUCRU website: www.oucru.orgJob summaryAn Ethics and Regulatory Specialist will support studies through the required ethical and regulatory approvals, help to prepare study documentation, track study progress, maintain approvals/documentation during the study, and liaise with the study sites to ensure the study is run in compliance with international guidelines and local regulations. The post holder will contribute to the continued growth and development of the CRMG-HCM teamKey responsibilities and tasks–

- Responsible for conducting all Science and Ethics committee submissions:





- Conducting protocol and study documents pre-reviews:
- Work with the trial staff for each new study to ensure the protocol and procedures comply with the applicable local and international regulatory standards.
- Review clinical trial protocols in order to identify inconsistencies, errors and omissions.
- Conducting the submission and tracking of regulatory and ethical applications for clinical research to relevant local and international bodies.
- Being key contact to communicate IRB decisions and rationale to investigators.
- Maintain regulatory filing of essential documents for each study in accordance with the principles of Good Clinical Practice.

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- Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international.

- Provide consultation/ education to investigators and research staff about the updated knowledge of human subject protection regulations and institutional policies.
- Provide guidance to staff regarding the policies of the Clinical Trials Unit and implementation of those policies.

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- Support the SAE reporting procedure, help PIs and coordinators to liaising with local ECs and MoH to send the SAE reports as required by the local ECs and MoH guideline

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- Contribute in the development of study and site procedures for good research governance.

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- Help study staff to develop appropriate ways to document all processes in a research study

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- Act as the primary contact for local and national regulatory bodies regarding clinical trials.

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- Perform general administrative duties as needed.

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- Verify study document translation (English –
- Vietnamese)

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- Contribute to the development of CRMG-HCM systems,



procedures and documentation, especially those relating to governance processes.

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- Attend career training to improve skills and update relevant knowledge

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- Assist actively with the organization and delivery of training in the guidelines of Good Clinical Practice

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- Other Tasks As Required.Selection CriteriaEssential

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- Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.

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- Excellent Vietnamese and English language skills.

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- Proven oral and written presentation skills.

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- Excellent diplomatic communication and interpersonal skills.

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- High level of organizational and record-keeping skills.

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- Understanding of ICH-GCP guidelines, local and international regulations on clinical research.

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- Self-starter, detail-oriented, self-confident.

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- Good time management, problem solver, flexible and adaptable.

Desired

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Experience in conducting, coordinating, monitoring or quality-assuring of clinical research.Benefits–

- Contracted salary:

- Grade: RS3/IC3
- Salary ranges: $1,262 – $1,546 gross per month

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- Optional insurance: In-patient and out-patient medical coverage
- Personal accident insurance coverage

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- Two months salary for annual bonus and clothes

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- Annual leave 18 days/year for the first year, a maximum of 30 days

Responsibilities

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- 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, either by email or by post to the following address:

Oxford University Clinical Research Unit

Laboratory of Clinical Science

Hospital for Tropical Diseases

764 Vo Van Kiet, Cho Quan Ward, District 5, HCMC

Email: [email protected]

- We thank all candidates for their interest but only short-listed applicants will be notified for interview. Contact personMs Nguyễn Thị
- Hồng PhúcDeadline for submission17 November 2026

📌 Ethics and Regulatory Specialist (JD-021) (Sulur)
🏢 Oxford University Clinical Research Unit
📍 Sulur