Clinical Research Assistant

PAANTHER research study 01 – ANRS 12229

Position: Full time work position. Consultancy with 12 months contract, extended every year until the end of the study (around 2-3 years).

Location: Pham Ngoc Thach Hospital, Ho Chi Minh City

Study: PAANTHER research study 01 – ANRS 12229: Improving diagnosis of Tuberculosis in HIV infected children in Asia (Cambodia, Vietnam) and in Africa (Burkina Faso, Cameroon).

Reporting: ANRS Clinical Trials Coordinator (PNT, HCMC) and to Asian Regional Project Manager (Pasteur Institute of Cambodia, Phnom Penh).

Objective of the study: To develop a new algorithm to improve the diagnosis of tuberculosis in HIV-infected children in the context of developing countries with high tuberculosis endemic. It is a
multicentre, longitudinal and prospective follow-up of 420 HIV-infected children suspect of intra-thoracic tuberculosis, diagnosed and treated according to national guidelines.

Duties/Responsibilities:
• Acts as liaison between the study sites and the Coordination Centre representing the sponsor of the study
• Ensures that the study is carried out in compliance with study protocol, Good Clinical Practices and the study procedures
• Ensures up-date and archiving of the study regulatory documents in both investigator and sponsor binders
• Provides patients study number and schedule to the Investigators
• Informs the Regional Coordination team of any new inclusion in Vietnam.
• Conducts regular monitoring visits to each site and produces a Monitoring Visit Report after each visit
• Controls the quality of consent forms and Case Report Forms and seek for missing data and correction of discrepancies
• Returns to the Coordination Centre all original validated fact sheets for Case Report Forms and copies of all other documents related to the study
• Sends requests for additional information for follow up to the sites and make sure that problems are solved in a timely manner. Forwards study listings to the sites
• Validates initial and supplementary reports on Serious Adverse Events and make sure that they are sent to the Regional Coordination Centre in a timely manner
• Inputs data into the database
• Participates in weekly Monitoring team meetings
• Assists the Clinical Trials Coordinator for translation Vietnamese-English-Vietnamese for documents, trainings and meetings

Requirements:
• Vietnamese native with good English verbal and writing skills,
• Qualified candidate possesses a bachelor's degree in life sciences (public health, epidemiology, biology or other related social science) with a minimum of two years experience in hospital or health settings)
• Autonomous with capacity to team work, excellent organizational and communication skills
• Understanding of research methodology and regulatory environment
• Demonstrated experience in computer skills to include Word, Excel and other basic templates.

CV and Cover letter to be sent to Mrs Catherine Quillet at [email protected] before the 20th of May 2012