INTERNAL MONITOR - Epicentre, Mbarara

Epicentre is a non-profit association, founded by Médecins Sans Frontières en 1987. It is in charge of operational research, clinical research, field epidemiology and training. Epicentre is a WHO collaborative centre for the research in epidemiology and response to emergent diseases. Epicentre follows its activities from its headquarters in Paris and from its offices in Geneva, Brussels, Barcelona, London, Barcelona, New-York and research centers in Uganda and Niger.

Epicentre in collaboration with the Mbarara University of Science and Technology have a research center in Mbarara, Uganda. Since 10 years now the partners are conducting a wide range of research, especially in conjunction with Mbarara Referral Hospital but also in the surrounding districts. The range of research includes observational, clinical and non clinical studies. Main indications researched are Malaria, CNS infections and Tuberculosis. Another field of interest is entomology.

Mission and Responsibilities
The recent growth of the study capacity and other research activities needs to be matched with trained and qualified research staff to ensure efficient and high quality standard research operations in line with international standards. The Internal Monitor will be required to monitor the existing research projects and assist in the execution of new projects as requested from the Principal Investigators (PI) and the Director of the research center The Internal Monitor will be under the responsibility of the Director of the research center and will work in close collaboration with the Principal Investigators.

General activities
• Monitor clinical trial sites as assigned with regards to protocol compliance and ICH-GCP requirements • Provide back up and support for external monitors and audits if required • Communicate with the sites the findings and follow up of all pending issues • Initiate and maintain the sponsor trial master file if appropriate • Ensure completeness and consistency of the study data with the PI and investigators of the study • Support and respond to requests from the trial site team members and the site/ country PI on trial related matters • Collaborate closely with the data-manager/statistician of the study for the data cleaning • Provide department support for coordination office duties, e.g. logistics and trainings • Be familiar with pharmaceutical regulatory requirements, documentation and processes within Uganda • Support and replace when necessary the research center pharmacovigilance/ drug monitoring responsible • Give assistance in ICH GCP training for the investigators if required • Put into pratice research protocols • Organize with the logistical department study material, such as, files, prints, stationary, etc. • Do the review of study related documents before submission, including amendments (Protocol: respective Monitoring and certain practical implications and safety section, CRF) • Participate in all trial relevant meetings and update the team on study progress • Perform other duties as assigned by the PIs and the Director of the research center Direct monitoring duties of studies :
• Monitor and maintain the investigator side file • Develop the monitoring plan • Verify the source data (CRF vs. clinical file documentation) as per study requirement • Monitor the screening and the recruitment and give support in maintaining the related tracking tools • Complete and maintain monitoring visit – logbook • Write a follow up letter for the study site after each monitoring visit • Write on a pre agreed frequency the monitoring report for the sponsor and the PI, and dispatch it after revision of PI • Verify the drug accountability in collaboration with the pharmacist and the PI • Develop and update monitoring SOP for the study under supervision of the PI • Liaise closely with the colleagues in the pharmacy (drug accountability), data management/statistics (verification of CRF and data bases), laboratory dpt (to monitor the timely sampling and knowledge of transportation for samples) • Provide assistance in development of study related clinical source documents • Initiate and coordinate external monitoring visits as pre agreed with sponsors, the PI and the Director • Any other assigned task by the responsible PIs and the Director Requirements
  • Minimum Bachelor degree, preferable in Nursing, Pharmacy, Life science or Biomedical science
  • Minimum 1 year of experience in all aspects of trial/ study conduct with emphasis on monitoring trial/ study conduct
  • Working experience in limited resource countries
  • Knowledge of ICH-GCP requirements
  • Excellent communication and interpersonal skills
  • High level of organizational and record keeping skills
  • Strong diplomatic skills
  • Excellent proven written and verbal English
  • Good IT skills in all common Windows applications
  • Knowledge of database architecture and basic use
  • Excellent team player and used to work in multiprofessional and multicultural teams
  • Willing to travel if required
  • Willing to take further training if required Desirable criteria: * Work experience with a medical research institution/ pharmaceutical industry * Project management experience * Recognized ICH-GCP certificate * Knowledge in SQL language
Conditions Volunteer MSF/Epicentre status 1 year contract starting mid-march 2012

Position based in Mbarara – Uganda
How to apply: 
Thank you for sending your CV and motivation letter before the 19th February 2012 by e-mail to Nathalie Guérineau :

For complementary information about this position please contact :Margarita Riera :

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