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:

• Ensure that the clinical trial is conducted in compliance with the approved protocol, GCP, and applicable regulatory requirements at the site level.
• Monitor the implementation of the study protocol at the site, addressing any issues or deviations promptly.
• Coordinate and supervise the activities of the site clinical research team, including nurses, technicians, and other staff.
• Facilitate communication and collaboration among the site team and investigators.
• Oversee participant recruitment, enrollment, and retention strategies to ensure target enrollment is achieved at the site.
• Ensure informed consent is obtained and documented appropriately.
• Ensure accurate and timely data collection and entry into electronic databases at the study site.
• Work closely with the Data Manager to resolve any data discrepancies or issues.
• Maintaining up to date regulatory binders for the study including the Study Master File (SMF) essential documents, delegation of duties log, training files.
• Oversee maintenance of Trial Master File and/or Investigator Site File (ISF)
• Planning and conducting internal site monitoring for the study and following up on proposed action plans.
• Maintain all regulatory documents at the site, including IRB approvals and informed consent forms.
• Monitor and report adverse events and ensure participant safety at the site..
• Preparing the sites for external study monitoring visits and writing post visit reports.
• Working with external monitors during monitoring visits and spearheading resolution of monitoring visit clarification forms.
• Works together with the study manager, principal investigators and relevant teams in ensuring timely submissions of progress reports/compliance documents to KEMRI SERU/PPB.

Vacancy Requirements:

• Bachelor’s Degree in Biomedical or Social sciences from a recognized University. A relevant Master’s Degree will be an added advantage    Mandatory
• Additional training in a management related field and research ethics including GCP/GCLP and trial management will be an added advantage    Added Advantage
• Competencies in GCP/GCLP reviews    Mandatory
• Excellent record keeping and filing skills    Mandatory
• Exceptional reporting and report writing skills in relation to research studies    Mandatory
• Ability to multitask, problem solve, and work with others to resolve challenges.    Mandatory
• Strong communication, training/teaching, leadership skills    Mandatory
• Excellent organizational skills and demonstrated competence with managing administrative records.    Mandatory
• Excellent interpersonal and communication skills; able to communicate effectively both orally and in writing    Mandatory
• Ability to monitor, gather and evaluate information of broad scope and complexity    Mandatory