Research Administrator (Regulatory) Job 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.

How To Apply

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