Frontieres (MSF) in 1987 to help improve the quality of its field
interventions. Since 1996, Epicentre has been a World Health Organization (WHO)
collaborating centre for research in epidemiology and response to emerging
diseases. Epicentre’s work hinges around three main activity areas: clinical
research, field epidemiology and training.
Research Assistant will act as the field principal investigator of a Yellow
fever study and will assume responsibility for the proper conduct of the trial
in coordination and under the supervision of the international principal
investigator and the Director of the centre.
Responsibilities:
- Ensure that the study is implemented in
compliance with the study protocol and that any deviations are properly
documented and communicated. - Actively
participate in the development and adaptation of Standard Operating
Procedures (SOPs). - The
incumbent will initiate and coordinate the process of obtaining
study approval from the local Regulatory Authorities and Ethics Committee
bodies, as applicable. - Submit
any substantial amendment of protocols or patient information and Informed
consent forms for approval to the local Regulatory Authorities and
Ethical bodies. - Plan
and execute the initial and continuous training of staff related to the
study in coordination with the international principal investigator and
study monitor. - Ensure
that all members of research team he/she is in charge of conduct the
study in accordance to GCP regulations in agreement with protocol and
study related SOPs. - Maintain
a Study Trial Investigator file containing all essentials documents. - Record
and promptly report Serious Adverse Reactions and other notifiable
events to Sponsor, relevant local ethics and regulatory authorities.
Experience:
- The
applicant should be a Medical doctor with advanced training in clinical
research, epidemiology or public health. - Additional
training in Good Clinical Practice. - Registered
with Medical and Dental Practitioners Council. - Previous
experience on clinical trial study implementation is an asset. - Extensive
knowledge of ICH guidelines, GCP, and the clinical trial study process. - Ability
to work effectively in teams as well as independently. - Excellent
verbal and written communication skills
their applications either by post or E-mail to:
[email protected]
5:30pm
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