Quality Assurance/Quality Control Officer

About the role

The Quality Assurance/Quality Control Officer ensures the scientific quality, integrity and timely execution of operational, clinical, epidemiological and laboratory-based research activities of AFRICOS. The role works with the Principal and Clinical Investigators, the AFRICOS Study Coordinator, the Head of the Department of Clinical Research on HIV of the NIMR-Mbeya and the partners at the Mbeya Zonal Referral Hospital and the Mbeya Regional Referral Hospital. It is based in Mbeya and reports to the Senior Research and Evaluation Advisor.

Key responsibilities

• Support the Principal Investigator, the Senior Research and Evaluation Advisor and the AFRICOS team in planning, implementing, monitoring and evaluating study activities.
• Assist in developing study documents such as budgets, protocol amendments, training materials, checklists, study logs and IRB submissions, in line with ICH-GCP.
• Help develop protocols, study tools, SOPs and implementation plans, and ensure compliance with protocols, GCP, GLP, regulatory and ethical requirements.
• Conduct routine quality checks on research data and coordinate its abstraction from patient records, laboratory reports, clinical databases and programme systems.
• Resolve data discrepancies, support corrective actions, and ensure secure, confidential storage of research data.
• Support evaluation of HIV prevention, treatment, retention, viral suppression, tuberculosis and cervical cancer screening interventions.
• Oversee collection, entry, validation and management of data, and develop and maintain data quality assurance procedures.
• Collaborate with laboratory personnel on assay quality and monitor laboratory documentation and quality control processes.
• Support participant retention, maintain accurate participant files and study records, and take part in data quality reviews.

Required profile

• Bachelor of Science degree in a laboratory or research science-related field.
• At least three years of experience in clinical research.
• Demonstrated experience as a Sub-Investigator or equivalent in clinical research studies.
• Experience with HIV/AIDS clinical programmes and research projects, including participant recruitment, informed consent and follow-up.
• In-depth understanding of clinical research principles, IRB approvals, protocol review, codes of ethics, quality management systems and accreditation standards.
• Fluent in English and Kiswahili.

Required skills

• Knowledge of GCP, GLP and research ethics.
• Proficiency in statistical and analytical software.
• Analytical, problem-solving and organisational skills, attention to detail and ability to work under pressure.