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I
QA/QC OFFICER
Infectious Diseases Institute
Posted TodayKampala
Location
Kampala
Job Type
Full-time
Experience
mid
Deadline
July 23, 2026
Category
Other
Job Description
To strengthen support to these core areas of operation, the IDI-Meningitis research group seeks to recruit a Quality Assurance/Quality Control (QA/QC) Officer to support the implementation of quality systems for clinical research studies by ensuring compliance with Good Clinical Practice (GCP), study protocols, sponsor requirements, and regulatory standards. The officer conducts quality reviews, supports audits and inspections, tracks corrective actions, and helps maintain accurate, complete, and inspection-ready study documentation.
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Requirements
- Strong organizational skills with excellent attention to detail and accuracy.
- Ability to review study documentation for quality, completeness, and compliance.
- Understanding of quality assurance principles, documentation practices, and continuous quality improvement.
- Good written and verbal communication skills, with the ability to work effectively with multidisciplinary research teams.
- Proficiency in Microsoft Office applications (Word, Excel, Outlook); familiarity with electronic quality management systems (eQMS), REDCap, or clinical trial management systems is an added advantage.
- Ability to prioritize multiple tasks and meet deadlines while maintaining high-quality standards.
- Ability to identify, document, and communicate quality issues and support implementation of corrective and preventive actions (CAPA).
- High level of integrity, professionalism, and ability to maintain confidentiality when handling sensitive research data.
Responsibilities
- Print, prepare, and organize participant files and source documents for use by the clinical team.
- Conduct daily quality control (QC) reviews of source documents, Case Report Forms (CRFs), informed consent forms, and other essential study records completed to ensure completeness, accuracy, and protocol compliance.
- Review source documents to ensure all study procedures are performed, documented, and completed within protocol-specified timelines.
- Ensure all completed and reviewed source documents are timely submitted for data entry.
- Ensure completed documents are properly filed in each participant's file and properly and securely stored in the filing cabinet.
- Work closely with the clinical team and the data management officer to review, resolve, and complete data queries, ensuring timely and accurate query resolution.
- Track protocol deviations, quality findings, and corrective and preventive actions (CAPAs) to ensure timely resolution.
- Support internal quality audits, sponsor monitoring visits, and regulatory inspections by maintaining inspection-ready documentation.
- Assist in the development and revision of Standard Operating Procedures (SOPs), quality checklists, and study tools.
- Identify quality gaps and contribute to continuous quality improvement initiatives across clinical studies.
- Collaborate with the clinical and study teams to promote data integrity, participant safety, and adherence to study protocols.
- Implement and maintain Quality Management Systems (QMS) in compliance with Good Clinical Practice (GCP), study protocols, sponsor requirements, and regulatory guidelines.
- Perform any other quality assurance and quality control duties assigned by the Trial Manager or Principal Investigator.
