Project Background:

The Meningitis Research Group aims to improve the diagnosis and treatment of various forms of meningitis in adults. Currently, 4 studies are running in Kampala and Mbarara:

COAST – an observational cohort study investigating etiologies and outcomes amongst adults presenting with meningitis.

HARVEST 2.0 - A Phase 2 Novel Antimicrobial Combination Therapy to Treat Tuberculous Meningitis

PLATFORM-CM - Platform Trial For Cryptococcal Meningitis.

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.

Key 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.

Academic Qualifications

• Bachelor's degree in Nursing, Biomedical Sciences, Public Health, Pharmacy, Laboratory Sciences, Social Sciences, or related field. Applicants with a diploma in a relevant field and at least four (4) years of relevant QA/QC experience will also be considered

Person Specification

Bachelor's degree in Nursing, Biomedical Sciences, Public Health, Pharmacy, Laboratory Sciences, Social Sciences, or related field. Applicants with a diploma in a relevant field and at least four (4) years of relevant QA/QC experience will also be considered

At least three (3) years of experience in clinical research, quality assurance, quality control, research administration, or clinical trial operations

Excellent knowledge of Good Clinical Practice (GCP), Human Subjects Protection (HSP), and Quality Management Systems (QMS).

Good understanding of clinical trial regulatory requirements in Uganda, including Research Ethics Committees (RECs/IRBs), the Uganda National Council for Science and Technology (UNCST), and the National Drug Authority (NDA).

Key Competencies and Skills

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.

• 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.

• 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.

• Bachelor's degree in Nursing, Biomedical Sciences, Public Health, Pharmacy, Laboratory Sciences, Social Sciences, or related field. Applicants with a diploma in a relevant field and at least four (4) years of relevant QA/QC experience will also be considered
• At least three (3) years of experience in clinical research, quality assurance, quality control, research administration, or clinical trial operations
• Excellent knowledge of Good Clinical Practice (GCP), Human Subjects Protection (HSP), and Quality Management Systems (QMS).
• Good understanding of clinical trial regulatory requirements in Uganda, including Research Ethics Committees (RECs/IRBs), the Uganda National Council for Science and Technology (UNCST), and the National Drug Authority (NDA).