Consultant
2025-07-15T07:46:53+00:00
CIIC-HIN
https://cdn.greatrwandajobs.com/jsjobsdata/data/employer/comp_3687/logo/CIIC-HIN.jpeg
https://ciichin.org/
FULL_TIME
kigali
Kigali
00000
Rwanda
Nonprofit, and NGO
Management
2025-07-25T17:00:00+00:00
Rwanda
8
Consultant to Review and Update Standard Operating Procedures for the Rwanda National Ethics Committee (RNEC)
Background
The Rwanda National Ethics Committee (RNEC) plays a critical role in safeguarding the rights, safety, and well-being of research participants in Rwanda. To ensure its continued compliance with international standards and to strengthen operational efficiency, the RNEC seeks to review and update its current Standard Operating Procedures (SOPs). This will include identifying procedural gaps, benchmarking against global best practices, and drafting any additional SOPs required for optimal functioning.
This initiative is part of the broader TRACE Project (Clinical Trials Regulatory and Ethics Systems Optimization Project), which aims to strengthen ethics and regulatory systems across Sub-Saharan Africa through harmonization, capacity building, and digital transformation. While TRACE spans multiple countries, this consultancy focuses specifically on Rwanda, supporting the institutional strengthening of RNEC within its national regulatory and digital context.
Objective of the Consultancy
To conduct a comprehensive review of the RNEC's current SOPs, identify procedural and content gaps, benchmark against internationally accepted standards and guidelines, and draft revised and/or new SOPs to enhance operational efficiency, alignment with digital transformation goals and compliance.
Scope of Work
The Consultant will be responsible for the following tasks:
- Review RNEC’s existing SOPs, policies, and operational documents, including those of IRBs.
- Conduct a gap analysis to identify inconsistencies, redundancies, and missing procedures.
- Benchmark current practices against international and regional standards (e.g., WHO, CIOMS, ICH-GCP, AVAREF) and align with national laws and systems (Rwanda FDA, NCST, RBC, IRBs).
- Engage RNEC leadership, secretariat, and key stakeholders to validate operational needs and coordination gaps.
- Propose an updated SOP framework that defines IRB roles, review pathways, and coordination mechanisms.
- Draft and revise SOPs, incorporating harmonized processes and digital integration (e.g., RHInnO Ethics).
- Recommend actions for capacity building, digital interoperability, and structural improvements.
- Submit draft and final SOPs for validation, ensuring all outputs remain confidential and the property of RNEC.
Deliverables
- Inception report outlining methodology and work plan.
- Gap analysis report comparing existing SOPs to international benchmarks.
- Draft revised SOPs and proposed new SOPs for stakeholder review.
- Final SOPs incorporating stakeholder feedback.
- Final report summarizing the process, key changes, and recommendations.
Duration and Timeline
The consultancy will last for a period of 30 days, starting from the date of contract signing. A detailed timeline with milestones will be developed and agreed upon during the inception phase.
Qualifications and Experience
- Advanced degree in Bioethics, Public Health, Law, Medicine, or a related field.
- At least 5 years of experience in research ethics, institutional review boards, or regulatory frameworks.
- Proven experience in developing or revising SOPs for ethics committees or similar regulatory bodies.
- Familiarity with international guidelines and Rwanda’s regulatory environment regarding research, ethics, and data protection
- Strong analytical, writing, and facilitation skills.
- Prior work with national ethics committees or ministries of health is an asset.
Reporting
The Consultant will report to the RNEC leadership team and work in close collaboration with the designated RNEC technical working group. Regular check-ins will be scheduled to ensure alignment.
Qualifications and Experience Advanced degree in Bioethics, Public Health, Law, Medicine, or a related field. At least 5 years of experience in research ethics, institutional review boards, or regulatory frameworks. Proven experience in developing or revising SOPs for ethics committees or similar regulatory bodies. Familiarity with international guidelines and Rwanda’s regulatory environment regarding research, ethics, and data protection Strong analytical, writing, and facilitation skills. Prior work with national ethics committees or ministries of health is an asset.
JOB-6876076dcb723
Vacancy title:
Consultant
[Type: FULL_TIME, Industry: Nonprofit, and NGO, Category: Management]
Jobs at:
CIIC-HIN
Deadline of this Job:
Friday, July 25 2025
Duty Station:
Kigali | Rwanda
Summary
Date Posted: Tuesday, July 15 2025, Base Salary: Not Disclosed
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JOB DETAILS:
Consultant to Review and Update Standard Operating Procedures for the Rwanda National Ethics Committee (RNEC)
Background
The Rwanda National Ethics Committee (RNEC) plays a critical role in safeguarding the rights, safety, and well-being of research participants in Rwanda. To ensure its continued compliance with international standards and to strengthen operational efficiency, the RNEC seeks to review and update its current Standard Operating Procedures (SOPs). This will include identifying procedural gaps, benchmarking against global best practices, and drafting any additional SOPs required for optimal functioning.
This initiative is part of the broader TRACE Project (Clinical Trials Regulatory and Ethics Systems Optimization Project), which aims to strengthen ethics and regulatory systems across Sub-Saharan Africa through harmonization, capacity building, and digital transformation. While TRACE spans multiple countries, this consultancy focuses specifically on Rwanda, supporting the institutional strengthening of RNEC within its national regulatory and digital context.
Objective of the Consultancy
To conduct a comprehensive review of the RNEC's current SOPs, identify procedural and content gaps, benchmark against internationally accepted standards and guidelines, and draft revised and/or new SOPs to enhance operational efficiency, alignment with digital transformation goals and compliance.
Scope of Work
The Consultant will be responsible for the following tasks:
- Review RNEC’s existing SOPs, policies, and operational documents, including those of IRBs.
- Conduct a gap analysis to identify inconsistencies, redundancies, and missing procedures.
- Benchmark current practices against international and regional standards (e.g., WHO, CIOMS, ICH-GCP, AVAREF) and align with national laws and systems (Rwanda FDA, NCST, RBC, IRBs).
- Engage RNEC leadership, secretariat, and key stakeholders to validate operational needs and coordination gaps.
- Propose an updated SOP framework that defines IRB roles, review pathways, and coordination mechanisms.
- Draft and revise SOPs, incorporating harmonized processes and digital integration (e.g., RHInnO Ethics).
- Recommend actions for capacity building, digital interoperability, and structural improvements.
- Submit draft and final SOPs for validation, ensuring all outputs remain confidential and the property of RNEC.
Deliverables
- Inception report outlining methodology and work plan.
- Gap analysis report comparing existing SOPs to international benchmarks.
- Draft revised SOPs and proposed new SOPs for stakeholder review.
- Final SOPs incorporating stakeholder feedback.
- Final report summarizing the process, key changes, and recommendations.
Duration and Timeline
The consultancy will last for a period of 30 days, starting from the date of contract signing. A detailed timeline with milestones will be developed and agreed upon during the inception phase.
Qualifications and Experience
- Advanced degree in Bioethics, Public Health, Law, Medicine, or a related field.
- At least 5 years of experience in research ethics, institutional review boards, or regulatory frameworks.
- Proven experience in developing or revising SOPs for ethics committees or similar regulatory bodies.
- Familiarity with international guidelines and Rwanda’s regulatory environment regarding research, ethics, and data protection
- Strong analytical, writing, and facilitation skills.
- Prior work with national ethics committees or ministries of health is an asset.
Reporting
The Consultant will report to the RNEC leadership team and work in close collaboration with the designated RNEC technical working group. Regular check-ins will be scheduled to ensure alignment.
Work Hours: 8
Experience in Months: 60
Level of Education: postgraduate degree
Job application procedure
Interested candidates should submit:
- A cover letter outlining relevant experience and motivation.
- A detailed CV with at least three professional references.
- Copies of academic certificates.
Subject line: Application – TRACE Consultant SOP Review
If you believe you meet the above requirements and wish to view a more detailed job description and wish to apply,
visit this link: https://ciichin.org/bioethics-consultant/
The application deadline is Friday, 25th July 2025.
Incomplete files or late applications will not be considered.
Only shortlisted candidates will be contacted.
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