Regulatory Officer (The University of North Carolina in Vietnam)

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 of 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 clinical trials of HIV/AIDS Prevention Trial Network (HPTN) and AIDS Clinical Trial Group (ACTG).

We have been conducting HPTN 083, a clinical trial to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). This study is conducted by The University of North Carolina (UNC), Hanoi Medical University in a cooperation with the 198 Hospital for 6 years.

In addition to the HPTN 083 study, we are currently one of the research sites selected for a new clinical trial which is a study looking at hepatitis B vaccination in adults living with HIV. The study will involve individuals who have received a previous hepatitis B vaccination, but the vaccine did not respond well and individuals who have never received the vaccination. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.

We are also preparing for TB treatment clinical trials to test a new TB regimen for MDR-TB patients and their Household Contacts.

We are now seeking a talented, dedicated and committed individual to join our team with the position of Regulatory Officer working at UNC’s project sites in Hanoi.

Position: Regulatory Officer
Full-time, based in Hanoi
Report to: Regulatory Manager 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 durring 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.

Duties & 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 authorites 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 availablility 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.

Required qualification and skills:

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

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 lylm@live.unc.edu (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 1 Sep 2022.

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