Reports to Head Research Operations. The incumbent will ensure all research studies at CIDRZ are in compliance with Good Clinical Practice (GCP) and regulatory requirements. This includes 10% QA/QC activities at various CIDRZ sites to ensure participant safety and data integrity. 

Maide Duties:

• Ensures compliance with all relevant Zambian research regulations and guidelines as well as local research ethics guidelines.
• 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 and done in accordance to their guidelines and within their stipulated timelines.
• Ensures that all protocol violations/deviations and SAEs are reported in a timely manner in accordance to EC and RA reporting requirements.
• Participates in DHMT, ZAMRA, NHRA and Ethics bi-annually progress reports
• QA/QC Activities
• Achieves an understanding of the objectives of assigned research studies and assist in development and maintenance of study-specific Quality Management plans, QC tools, etc
• Reviews participant charts at least monthly for assigned studies to ensure compliance with the protocol and ethical guidelines and document findings.  A minimum 10% review of participant charts should be completed quarterly. 
• Tracks study-specific QC performance indicators and trends and provide feedback to study teams at least quarterly.
• Ensures that the consenting process of at least three participants is observed for compliance with ethical guidelines.
• Participates in internal and external monitoring visits as required.
• In coordination with Study Coordinator and Clinical Coordinator, develops actions plans for corrective measures on a study-by-study basis to ensure compliance with protocol and quality goals and to ensure resolution of identified issues.
• Communicates openly and honestly with new and established study teams on the oversight of ongoing CIDRZ Quality Assurance/Quality Management and regulatory compliance.
• Assist in preparing study related reports/presentations as necessary for study funders, and other interested parties.
• Communicate 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 the following: Regulatory: Human Subjects Protections, Regulatory files for Research, Essential Documents and other trainings e.g Source Documentation, ICF, Quality Assurance
• Any other duties or responsibilities found necessary for the successful implementation and functioning of research studies and the regulatory department.

Qualifications:

• Grade 12 certificate
• Bachelor's in health related field and master’s will be an added advantage.
• Proficient in Microsoft Programs
• Experience in setting up & conducting trainings
• At least 3 year’s experience in QA/QC and research activities
• Familiar with the Internal Quality Control/Assurance SOP
• 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.

Suitably qualified candidates are encouraged to apply. However, only shortlisted candidates will be contacted.