Regulatory Officer

JOB ANNOUNCEMENT – REGULATORY OFFICER

The University of North Carolina (UNC) is a project office of the University of North Carolina at Chapel Hill to conduct HIV prevention research in Vietnam. We have been conducting a number of randomized control trials (RCTs) both behavioral and clinical research in men and women from general and key populations in Vietnam for more than 15 years.

We are now seeking a talented, dedicated and committed individual to join our team in Vietnam to conduct exciting research studies.

Position: 01 Regulatory Officer
               Based in Hanoi.

Report to: Research Managers and In-country Director

Position 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. The Regulatory Officer will support studies through the required ethical and regulatory approvals, help to prepare study documentation, track the study reports, maintain approvals/documentation during the study in compliance with protocol specifications, applicable guidelines, regulatory requirements, and SOPs. The post holder will contribute to the continued growth and development of the UNC team.

SPECIFIC ROLES & RESPONSIBILITIES:

Primary duties and responsibilities for the incumbent of this position may include, but are not limited to the following:

• Assist In-Country Director and Research Managers with the creation, submission and tracking of regulatory and ethical applications and obtain approvals from relevant local authorities and Institutional Review Boards (IRBs) for clinical research.
• Submits continuations/amendments and reports to IRBs to maintain compliance with regulatory requirements and institutional policies.
• Develop relevant standard operating procedures (SOPs) with respect to regulatory, including essential documents, communication with IRBs or personnel qualifications.
• Maintain regulatory filing of essential documents of each study to ensure optimal research compliance with UNC-CH standardization.
• Edit clinical research trial consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent. Translate complicated research protocol requirements into language easily understandable by research participants.
• Proactively assist in monitoring visits, audits or regulatory inspections. Ensure the availability of regulatory documents for expedient retrieval and inspection as requested by authorized monitors/inspectors.
• Perform Quality Assurance checks on regulatory files and informed consent forms.
• Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international.
• Translate project documents (English-Vietnamese-English) as required.
• Perform other tasks as requested by the In-Country Director.

Required qualification and skills:

• Bachelor’s Degree in Science, Public Health or a related field
• Excellent communication and interpersonal skills
• High level of organizational and record keeping skills
• Excellent Vietnamese and English language skills

Preferred:

• Knowledge of Good Clinical Practice Guidelines
• Knowledge of local and international research regulations
• Experience in clinical research regulatory role

Salaries and Benefits: Competitive salary

How to Apply:

Interested candidates are invited to email a cover letter with contacts for three references and a CV to Mrs. Luong Thi My Ly at [email protected] (in the subject line, please put “Regulatory Officer”), or by post to the UNC office at Room 407-408, Building A2, Van Phuc Diplomatic Compound, 298 Kim Ma street, Ba Dinh district, Hanoi no later than 05 March 2021

We are sorry that only short-listed candidates will be contacted for interview.