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Research Administrator (Regulatory) - Mtwapa

Closing: Jul 23, 2024

4 days remaining

Published: Jul 4, 2024 (16 days ago)

Job Requirements

Education:

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Job Summary

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Vacancy Requirements:

i.Bachelor of Science Degree, Social Sciences or a health-related discipline

ii.Training on Regulatory Affairs/Quality Assurance/Clinical trials will be an added advantage

iii.Fluency in Kiswahili and English – both written and oral

iv.Training in Good Clinical Practice (GCP) and other applicable regulations


Responsibilities

Vacancy Requirements:

i.Bachelor of Science Degree, Social Sciences or a health-related discipline

ii.Training on Regulatory Affairs/Quality Assurance/Clinical trials will be an added advantage

iii.Fluency in Kiswahili and English – both written and oral

iv.Training in Good Clinical Practice (GCP) and other applicable regulations


  • i.Maintain studies’ compliance with applicable guidelines and regulations as well as all relevant local laws at all times,
  • ii.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,
  • iii.Maintain documents as required by regulatory agency guidelines,
  • iv.Organize, coordinate, and document all training undertaken in respect to the study and to file all the relevant training records,
  • v.Conduct periodic internal monitoring and audits of studies to ensure compliance with the protocol, SOPs, GCP and all the applicable regulations,
  • vi.Tracking, documenting, and reporting adverse events,
  • vii.Writing and reviewing of Standard Operating Procedures,
  • viii.Developing of study source documents,
  • ix.Any other duties assigned by the immediate supervisor.


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