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). In order to expand our operations, we are now seeking a talented, dedicated and committed individual to join our team.

Position:         Clinical Research Coordinator
                       Full-time, based in Hanoi

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

Position Summary:

The Clinical Research Coordinator (CRC) will oversee and perform daily clinical trial activities to ensure the studies are conducted in compliance with protocols, local and international requirements. By performing these duties, the CRC works with participants, Clinicians and other study staff, IoR, PIs, Lab team, Pharmacy team, Recruitment team, UNC-CH experts, monitors,  and IRBs to provide guidance and support on routine tasks at clinical research sites,  technical issues and other related aspects of all ongoing clinical studies.

Duties & Responsibilities:

• Develop SOPs on clinical and safety activities for clinical trials based on throughout understanding of the protocols.
• Develop study tools and forms to record study data per protocols, GCP,  networks, sponsors, IRBs and other regulatory entities requirements.
• Provide training and technical assistance for clinicians and other study staff on daily study activities.
• Provide training and technical assistant for clinicians on informed consent process. Ensures that the informed consent process is conducted per applicable regulations.
• Assess the inclusion and exclusion criteria for participant enrollment and verify participant’s documents for randomization.
• Perform monitoring activities on daily basis, ensuring compliance of clinical activities with protocol, GCP, Vietnam laws and regulations, including but not limited to reviewing of informed consent, participant chart,  AE/SAE report, etc.
• Ensure that AEs and participant safety are managed per applicable requirements. Complete AE/SAE and safety reports to send to IoR, PI, sponsor, and IRB in a timely manner.
• Ensure that the study documents are kept and maintained per current regulations.
• Work closely with the clinical management committee (CMC) to seek advice on dealing with difficult cases and situations.  
• Ensure that the study documents are kept and maintained per current regulations.
• Promote study participant recruitment and retention in the research studies.
• Translate study documents from English into Vietnamese and vice versa.
• Be a role model, share best practices and make recommendations for continuous quality improvement in clinical activities.
• Attend study specific and study related trainings and meetings as requested.
• May perform other job related duties as requested or required.

Required qualification and skills:

• Bachelor degree’s in Medicine, Public Health,  or other Health Sciences.
• Fluent in both spoken and written English.
• Excellent interpersonal and organizational skills.
• Good knowledge of the good clinical practice (GCP).
• 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 January 2022.

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