KEMRI
23 days ago
07/04/2024
08/03/2024
Research Administrator (Regulatory) Mtwapa
KilifiKE
The 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 as the national body res...
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.
KilifiKE
Bachelor
Healthcare