Regulatory Coordinator – Suba/Rongo
- Advertised Date: 08/15/24
- Closing Date: 09/04/24 5:00:00 PM
- Applications: 31
Job Tite/Designation
Regulatory Coordinator – Suba/Rongo
Key Responsibilities:
- i.Leading development and maintenance of Study Master File/Investigator Site Files
- ii.Preparing the sites for external study monitoring visits and writing post visit reports
- iii.Acts for and on behalf of the study Coordinator with regards to regulatory compliance
- iv.Works together with the study coordinators/HoDs in ensuring timely submissions to KEMRI SERU/PPB
- v.Oversee maintenance of Trial Master File and/or Investigator Site File (ISF)
- vi.Maintaining up to date regulatory binders for the study including the Study Master File (SMF) essential documents, delegation of duties log, training files, etc
- vii.Planning and conducting internal site monitoring for the study and following up on proposed action plans
- viii.Working with external monitors during monitoring visits and spearheading resolution of monitoring visit clarification forms
- ix.Coordinating and documentation of study related internal trainings/curricular
- x.Active role in review process for study SOPs
- xi.Checking and ensuring regulatory compliance by all departments of the study
- xii.Working with the Clinic team on Protocol deviations/violations and SAE/UAE reporting especially with regards to maintenance of logs and filing of reports
- xiii.Working with respective departments on implementation of the Study Quality Management Plan
- xiv.Other duties as delegated by the Study Coordinator/PI
- xv.In the absence of the Regulatory Coordinator, one of the regulatory officers assumes the responsibilities of the coordinator in consultation with the study Coordinator/PI.
Vacancy Requirements:
| # | Description. | Requirement Type |
|---|---|---|
| 1 | i.Bachelor’s Degree in Health or social sciences from a recognized university. A relevant Master’s Degree is preferred | Mandatory |
| 2 | ii.Additional training in a management related field and research ethics is an added advantage | Added Advantage |
| 3 | iii.Mandatory 2 years of busy Proven clinical research experience working on ethical/regulatory submissions to applicable IRBs. | Mandatory |
| 4 | iv.Valid practicing license where applicable | Mandatory |
| 5 | i.Comfortable with paperwork with a strong bias towards GCP/GCLP reviews | Skills & Competencies |
| 6 | ii.Excellent record keeping and filing skills | Skills & Competencies |
| 7 | iii.Exceptional reporting and report writing skills in relation to research studies | Skills & Competencies |
| 8 | iv.Ability to multitask, problem solve, and work with others to resolve challenges. | Skills & Competencies |
| 9 | v.Strong communication, training/teaching, leadership skills | Skills & Competencies |
| 10 | vi.Excellent organizational skills and demonstrated competence with managing administrative records. | Skills & Competencies |
| 11 | vii.Excellent interpersonal and communication skills; able to communicate effectively both orally and in writing | Skills & Competencies |
| 12 | viii.Ability to monitor, gather and evaluate information of broad scope and complexity | Skills & Competencies |
Apply Online
Job Type
Contract
No. of Vacancies
1
Job Grade
KMR 05
Location
Contact Email Address
Application Ends on: 09/04/24 5:00:00 PM
Application Procedure:
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- 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.