KENYA MEDICAL RESEARCH INSTITUTE E-RECRUITMENT PORTAL
Key Responsibilities:
- i. Ensure that the clinical trial is conducted in compliance with the approved protocol, GCP, and applicable regulatory requirements at the site level.
- ii. Monitor the implementation of the study protocol at the site, addressing any issues or deviations promptly.
- i. Coordinate and supervise the activities of the site clinical research team, including nurses, technicians, and other staff.
- ii. Facilitate communication and collaboration among the site team and investigators.
- i. Oversee participant recruitment, enrollment, and retention strategies to ensure target enrollment is achieved at the site.
- ii. Ensure informed consent is obtained and documented appropriately.
- i. Ensure accurate and timely data collection and entry into electronic databases at the study site.
- ii. Work closely with the Data Manager to resolve any data discrepancies or issues.
- iii. Maintaining up to date regulatory binders for the study including the Study Master File (SMF) essential documents, delegation of duties log, training files.
- iv. 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.
- i. Maintain all regulatory documents at the site, including IRB approvals and informed consent forms.
- ii. Monitor and report adverse events and ensure participant safety at the site..
- iii. Preparing the sites for external study monitoring visits and writing post visit reports.
- i. Working with external monitors during monitoring visits and spearheading resolution of monitoring visit clarification forms.
- ii. 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:
| # | Description. | Requirement Type |
|---|---|---|
| 1 | Bachelor’s Degree in Biomedical or Social sciences from a recognized University. A relevant Master’s Degree will be an added advantage | Mandatory |
| 2 | Additional training in a management related field and research ethics including GCP/GCLP and trial management will be an added advantage | Added Advantage |
| 3 | Competencies in GCP/GCLP reviews | Mandatory |
| 4 | Excellent record keeping and filing skills | Mandatory |
| 5 | Exceptional reporting and report writing skills in relation to research studies | Mandatory |
| 6 | Ability to multitask, problem solve, and work with others to resolve challenges. | Mandatory |
| 7 | Strong communication, training/teaching, leadership skills | Mandatory |
| 8 | Excellent organizational skills and demonstrated competence with managing administrative records. | Mandatory |
| 9 | Excellent interpersonal and communication skills; able to communicate effectively both orally and in writing | Mandatory |
| 10 | Ability to monitor, gather and evaluate information of broad scope and complexity | Mandatory |
Application Procedure:
To apply for this post you must be a registered user. Log into your account then go to Vacancies, view the post and click on the button: "Apply for this job".
- Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate (certificate of good conduct) during the interviews.