QA/QC Officer

Qualifications and Experience

• 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).
  

• 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.