Regulatory Officer

JOB ANNOUNCEMENT – REGULATORY OFFICER

The University of North Carolina in Vietnam is a research organization of the University of North Carlina at Chapel Hill, USA. Our missions are conducting clinical research on new treatment methods for HIV prevention, TB treatment, mental health in both treatment and behavior changes for people living with HIV, TB patients, men who have sex with men and people who inject drug. Our partners are Hanoi Medical University, Hospitals in Hanoi, Provincial CDCs nationwide. We are conducting both clinical trials of the HIV/AIDS Prevention Trial Network (HPTN) and AIDS Clinical Trial Group (ACTG). In order to expand our operations, we are now seeking a talented and dedicated individual to join our team.

Position: Regulatory Officer
Full-time, based in Hanoi.

Report to: Regulatory Manager and In-country Director

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. 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.

Key tasks and 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 Regulatory Manager 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.
• Submit 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 and Regulatory Manager.

Requirement

• Bachelor’s Degree in Foreign Languages, 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
• Strong verbal and written communications skills
• Fluent spoken and written English
• Proficiency in Microsoft Office software
• Familiarity with statistical software research, (SPSS/Stata/EpiData, Nvivo…)

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 Ms. Tran Thi Thu Hoai at hoaitran@live.unc.edu and cc to Ms. Nguyen Thi Ngoc Phuong at phuong.ntn@unc.edu.vn (in the subject line, please put “Regulatory Officer _ full name”), 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 17:00, 23 Jul 2023.

We review applications on a rolling basic.

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