Ethics and Regulatory Specialist

Position: Ethics and Regulatory Specialist
Department: Clinical Trial Unit (CTU)
Working condition: This post is based in Ho Chi Minh City, Vietnam.  Travel to hospitals or units around Ho Chi Minh City will be required regularly.  Travel within Vietnam or internationally will be required.
Hours of work: Full-time
Tenure: This is a 1 year position with possibility of extension
Supervisor: Head of Research Governance
Vacancy reference: JD-0516-014

Background

Oxford University has a Clinical Research Unit in Vietnam working in partnership with the Hospital for Tropical Diseases in Ho Chi Minh City and a network of hospitals across Vietnam and Asia to conduct a wide range of clinical studies including clinical trials of drugs and vaccines.  The Unit is based in the Hospital for Tropical Diseases in Ho Chi Minh City.  The Unit’s main focus of work is in Typhoid, Dengue, Infections of the Central Nervous System, Influenza, Malaria, Tetanus, Influenza, HIV and Tuberculosis.  Research operations are managed by the Clinical Trials Unit (CTU), which has seen considerable recent growth to accommodate for increasing numbers of trials. A highly motivated research staff is required to manage the implementation of new research projects and to support and develop the current activities of the Clinical Trials Unit.  

The post-holder will be based within the OUCRU-VN Clinical Trials Unit and be responsible for research ethics, research regulation and research administration activities for studies conducted by OUCRU-VN. 

Job summary

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with high level research governance to ensure safe and high quality research in line with international standards. An 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, liaise with the study site to ensure the study is run in compliance with the guidelines of Good Clinical Practice of the International Conference on Harmonization, the Medical Research Council-UK, the Vietnam Ministry of Health or other local regulatory authorities.  The post holder will contribute to the continued growth and development of the CTU team. 

Key responsibilities and tasks

• Assist with the creation, submission and tracking of regulatory and ethical applications for clinical research to relevant local and international bodies.
• Maintain regulatory filing of essential documents for each study in accordance with the principles of Good Clinical Practice.
• Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international.
• 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.
• Provide guidance to staff regarding the policies of the Clinical Trials Unit and implementation of those policies.
• Assist in the development of study and site procedures for good research governance.
• Help study staff to develop appropriate ways to document all processes in a research study
• Plan logistical requirements of new clinical studies.  Create ways to track and inventory study consumables and samples.
• Act as the primary contact for local and national regulatory bodies regarding clinical trials.
• Perform general administrative duties as needed.
• Write and file contracts between OUCRU-VN and other stakeholders to address issues on funding material transfer and confidentiality according to established policies.
• Translate study documents (Vietnamese - English – Vietnamese)
• Contribute to the development of CTU systems, procedures and documentation, especially those relating to governance processes.
• Attend career training to improve skills and update relevant knowledge
• Assist with the organization and delivery of training in the guidelines of Good Clinical Practice
• Other tasks as required.

Selection criteria

Essential:

• Degree in Nursing, Pharmacy, Science, Public Health or a related field
• Strong diplomatic skills
• Proven oral and written presentation skills
• Excellent communication and interpersonal skills
• High level of organizational and record keeping skills
• Excellent Vietnamese and English language skills

Desired:

• Administrative experience
• Translation experience
• Knowledge of Good Clinical Practice Guidelines
• Experience in clinical research
• Knowledge of local and international research regulations

How to apply

Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant 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, Ward 1, District 5, HCMC
Email: [email protected]

Only short-listed candidates will be contacted for interview.

Contact person: Ms. Nguyen Thi Hong Phuc

Deadline for submission: 1st June 2016