Principal Investigator
created a permanent research centre in Uganda to support MSF projects in the
region. The primary role of Epicentre in Mbarara is to conduct clinical
research following Good Clinical Practice (GCP) requirements on critical public
health burdens in Uganda and Africa. To reach this objective, Epicentre
collaborates closely with the Mbarara University of Science and Technology
(MUST). A full-time experienced research team is based at the Epicentre Mbarara
Research Centre. The Mbarara research centre is located in Mbarara
Municipality, 300 km South-West to Kampala.
for the proper conduct of the trial in coordination and under the supervision
of the Principal Investigator and the Vaccine Trial Coordinator.
with the Vaccine Trial Coordinator, ensure good compliance with the framework
of the study:
- Ensure that the study is implemented in compliance with the study
protocol and in accordance with GCP regulations - Participate in the development and adaptation of Standard Operating
Procedures - Ensure that Standard Operating Procedures are implemented
- Promptly document and communicate any protocol deviations
- Record and promptly report Serious Adverse Reactions and other
notifiable events to the Sponsor, relevant local ethics and regulatory
authorities - Maintain a Study Trial Investigator file containing all essentials
documents
with the Vaccine Trial Coordinator, supervise the study:
- Ensure that data is collected, recorded, handled, stored and
reported accurately on Case Report Forms - Ensure the adequate medical care of study participants for any
adverse event - Monitor study materials including but not limited to drugs,
sundries, diagnostic tools - Prepare, together with the pharmacist, medical orders needed for the
running of the study
supervision and follow-up of the study staff
- Plan and execute the initial and continuous training of staff
related to the study in coordination with the principal investigator,
study monitor and vaccine trials coordinator - Supervise and advise the study doctors, nurses, field workers in
performance of their duties
- Communicate regularly with principal investigator and the vaccine
trial coordinator - Generate timely study reports and contribute to writing of monthly
site - Participate regularly in meetings and other activities of the
medical department and the research centre as a whole when required - Take up any other responsibilities delegated by the vaccine Trial
Coordinator or Director of the Centre - Ensure good communication with other investigators and the study
team - Initiate and coordinate the process of obtaining study approval from
the local Regulatory Authorities and Ethics Committee bodies, as
applicable, including amendments of protocol and informed consent forms
and regular reports.
- The applicant must hold a Medical doctor with advanced training in
clinical research, epidemiology or public health - Previous experience on clinical trial study implementation
- Knowledge of ICH guidelines, GCP, and the clinical trial study
process - Ability to work effectively in teams as well as independently
- Strong verbal and written communication skills
- Training in Good Clinical Practice
qualified and interested candidates should hand deliver their application
package (CV, application letter and copies of their academic / work
certificates) to:
Mbarara Research Centre,
Mbarara,
to: [email protected]
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