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Research Administrator
4 weeks ago
Kenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013.
The 1979 Act established KEMRI as a National body responsible for carrying out health research in Kenya.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.
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