Research Administrator (Regulatory) - Mtwapa

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.