Clinical Research Assistant

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 studies
- Ensures that the studies are carried out in compliance with study protocol, Good Clinical Practices and the studies procedures
- Ensures up-date and archiving of the studies 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 studies
- 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 before the 30th of April 2012
Email: [email protected]