Clinical Research Coordinator

The University of North Carolina at Chapel Hill (UNC) was chartered in 1789 and opened its doors to students in 1795 as the first public university in the United States (US).  The University is among the top research universities in the US, ranking 9th among the top 100 academic institutions in federally financed research and development in the US, according to The Chronicle of Higher Education.

The UNC research team has been conducting research in northern Vietnam for 15 years. We have been conducting a number of randomized control trials (RCTs). The UNC-Vietnam team has expertise with both socio-behavioral and clinical research and has studied a variety of infectious diseases and comorbid conditions in men and women from general and key populations.

We are on the site activation stage for the HPTN 083 study “A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men”

Position:    01 Clinical Research Coordinator

Based in Hanoi.

Report to:    The UNC Project Director in Vietnam

Position Summary:

The position arranges and oversees all clinical trial activities. The position will work closely with the site physicians to support and provide guidance on the administration of the compliance, technical issues and other related aspects of all ongoing clinical studies.

SPECIFIC ROLES & 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, ect…
  • 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 work flow.
  • 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 send a cover letter with contacts for three references and a CV to Ms. Tran Thi Thu Hoai at [email protected] (in the subject line, please put “UNC Clinical Research Coordinator ”), or by post to the UNC office at Yen Hoa Health Clinic: Lot E2, Duong Dinh Nghe Street, Cau Giay District, Hanoi  no later than 14 Feb 2017

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

Job Details
Organisation Name: 
The University of North Carolina at Chapel Hill (UNC)
Location: 
Hanoi
Application Deadline: 
Tue, 2017-02-14