Reports to Head of Research Operations. The incumbent will ensure compliance with Zambian and international research regulations and ethical guidelines. He/she will be responsible for managing submissions to ethics committees, ZAMRA, NHRA, and other regulatory bodies, ensuring timely approvals. He/she will also serve as a liaison between study teams and regulatory bodies, maintain submission records, and coordinate progress reports

Main Duties:

• Be knowledgeable about and ensures compliance with all relevant Zambian research regulations and guidelines as well as local research ethics guidelines.
• Be knowledgeable of international research regulations including International Conference on Harmonization (ICH) guidelines, the US Code of Federal Regulations, relevant ethics committee procedures, and research sponsor Standard Operating Procedures.
• Ensures international ethics approval for those affiliated with international universities and tracks expiry dates to ensure timely continuing review.
• Ensures timely review of all documents submitted to the department within stipulated timelines from the Research Ops SOPs.
• Ensures proficiency in Rhinno Ethics electronic system for all submission to UNZABREC and NHRA
• Ensures proficiency in the IRIMS electronic system for all ZAMRA submissions
• Ensures all submission to UNZABREC, NHRA, ZAMRA and NBA are done in accordance with their guidelines and within their stipulated timelines.
• Acts as liaison person between study teams and the Research Ethics Committee (REC) and regulatory bodies to ensure timely submission and approval of all study-related materials.
• Accurately maintains scanned records of all study submissions and approvals from the REC and other regulatory bodies according to departmental guidelines.
• Helps coordinate IBC activities (meetings, inspections and external reviewer payments)
• Ensures that all protocol violations/deviations and SAEs are reported in a timely manner in accordance with EC and RA reporting requirements.
• Participates in DHMT, ZAMRA, NHRA and Ethics bi-annually progress reports
• Participates in stake holder meetings as required.
• Ensure that all past and present study protocols, ethics and regulatory approvals are saved on the server.
• Communicates openly and honestly with new and established study teams on the oversight of ongoing CIDRZ Quality Assurance/Quality Management and regulatory compliance.
• Assists in preparing study related reports/presentations as necessary for study funders,and other interested parties.
• Communicates new information from Ethics and Regulators
• Educates and mentors study staff and provide individual guidance for quality improvement as required.
• Assists in building institutional capacity to sustain quality assurance and regulatory compliance activities within CIDRZ.
• Assists in identifying training needs, develop and provide training programs as necessary to update/maintain competence of study staff. Training programs include but are not limited to Human Subjects Protections, Research Essential Documents, Source Documentation, ICF, Quality Assurance

Qualifications:

• Grade 12 certificate
• Diploma in health-related field. Bachelors or Master’s will be an added advantage
• Proficient in Microsoft Programs
• Experience in setting up & conducting trainings
• Experience in research activities
• Clinical Research Coordination (CRC) Training
• Training in Bioethics
• Excellent knowledge of grant writing and submission process

Suitable candidates are encoraged to apply. However, only shortlisted candidates will be contacted