Key Responsibilities:
Maintain studies’ compliance with applicable
guidelines and regulations as well as all relevant local laws at all times,
Keep track of all study protocols at the various IRBs
and the regulatory body with an aim of ensuring strict adherence to
submission/reporting timelines,
Maintain documents as required by regulatory agency
guidelines,
Organize, coordinate, and document all training
undertaken in respect to the study and to file all the relevant training
records,
Conduct periodic internal monitoring and audits of
studies to ensure compliance with the protocol, SOPs, GCP and all the
applicable regulations,
Tracking, documenting, and reporting adverse events,
Writing and reviewing of Standard Operating
Procedures,
Developing of study source documents,
Any other duties assigned by the immediate
supervisor.
Vacancy Requirements:
Bachelor of Science Degree, Social Sciences or a
health-related discipline
Training on Regulatory Affairs/Quality
Assurance/Clinical trials will be an added advantage Added
Advantage
Fluency in Kiswahili and English – both written and
oral
Training in Good Clinical Practice (GCP) and other
applicable regulations.
How To Apply
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