• Responsibilities

Develop, review, and maintain Standard Operating Procedures (SOPs) related to CRSs.

Ensure document control systems are maintained, including version control, archiving, and controlled distribution.

Coordinating and conducting internal clinical quality audits and supporting external audits and inspections.

Monitoring protocol compliance, deviations, and non-conformances, ensuring proper documentation and reporting.

Track and follow up on corrective actions.

Coordinate Corrective and Preventive Actions (CAPA).

Supporting the implementation of training and competency systems for clinical research staff.

Conducting risk assessments and supporting clinical quality improvement initiatives.

Monitoring and reporting clinical quality indicators to management.

Guiding study teams on quality standards.

• Requirements

Bachelor’s degree in: Health Sciences / Nursing / Public Health.

Minimum 3-5 years of experience in clinical research.

At least 2 years in QA/QC, monitoring, or regulatory compliance.

Certification in QA/auditing (e.g., ISO, CQA) is an added advantage.

Experience in clinical trials (e.g., HIV, TB, vaccines, or public health research) is an advantage.