Clinical Research Coordinator

JOB ANNOUNCEMENT – CLINICAL RESEARCH COORDINATOR

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 a TB treatment clinical trials to test a new TB regimen for MDR-TB patients and their House Hold Contacts.

We are now seeking a talented, dedicated and committed individual to join our team with the position of Clinical Research Coordinator working at study site/Yen Hoa Health Clinic, Cau Giay Health District, Hanoi.

Position:        Clinical Research Coordinator
                      Full-time position. Based in Hanoi.

Report to:      Clinical Research Manager & Investigator of Record (IoR)

Position Summary:

The Clinical Research Coordinator (CRC) will oversee and perform the day to day clinical trial activities to ensure the studies are conducted in compliance with protocol, local and international requirements. By performing these duties, the CRC works with participant, IoR, Lab, Pharmacy, Recruitment, site physicians, UNC-CH experts to support and provide guidance on the administration of the compliance, technical issues and other related aspects of all ongoing clinical studies.

Duties & Responsibilities:

• Develops SOPs on clinical and safety activities in the HPTN 083 clinical trial based on throughout understanding of the protocol.
• Attends study specific and study related trainings and meetings as requested
• Develops of materials and tools, forms necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, ... Maintains records and other documentation of training.
• Provides training for physician on concerned SOPs and other administration tasks.
• Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
• Assess the inclusive and exclusive criteria for participant enrollment and verify participant’s documents for randomization.
• Performs source document verification of participant data and query resolution
• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
• Performs monitoring activities on daily basic, ensuring compliance of clinical activities with protocol, GCP, Vietnam laws and regulations, including but not limited to review of informed consent, AE/SAEs, etc.
• Work closely with a Physician Advisory Board of HPTN Network to have consultation on dealing with difficult cases. Complete AE/SAE report to send to the Head Quarter, PI and donor.
• Role model, share best practices and make recommendations for continuous quality improvement on clinical activities 
• Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
• May perform other job related duties as requested or required

Required qualification and skills:

• University degree for Medical Doctor,
• Working experience in HIV areas.
• Fluent in both spoken and written English
• Excellent interpersonal skills to deal effectively with clinicians, patients, sponsors, partners and colleagues.
• Knowledge of good clinical practice, FDA, OHRP (Office for Human Research Protection) policies.
• Familiarity with the Microsoft Office Suite. Excellent organizational skills to independently manage workflow.
•  Ability to prioritize quickly and appropriately.
•  Ability to multi-task.
•  Meticulous attention to detail

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 “Clinical Research Coordinator _ 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 31 December 2021.

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