Quality Assurance/Quality Control Officer (AFRICOS)
About the Organization
HJF Medical Research International, Inc. Tanzania (HJFMRI) implements PEPFAR-supported HIV care, treatment, and clinical research programs through the Walter Reed Army Institute of Research (WRAIR) of the US Department of Defense (DoD), in close collaboration with the Tanzanian Ministry of Health and PORALG. Operating across the Southern Highlands and through the Tanzania People’s Defense Forces (TPDF) program, HJFMRI advances high-impact public health interventions, laboratory services, and epidemiological studies.
Job Summary
HJFMRI is seeking a diligent and analytical Quality Assurance/Quality Control Officer to ensure the scientific quality, integrity, and timely execution of operational, clinical, epidemiological, and laboratory-based research activities for the AFRICOS study in Mbeya. Working alongside Principal Investigators, study coordinators, NIMR-Mbeya, Mbeya Zonal Referral Hospital (MZRH), and Mbeya Regional Referral Hospital (MRRH), the incumbent will guarantee that all study operations comply strictly with approved protocols, ICH-GCP guidelines, Good Laboratory Practice (GLP), and national regulatory requirements.
Key Responsibilities
1. Study Planning, Protocol Compliance & Documentation
- Support the Principal Investigator (PI), Senior Research and Evaluation Advisor, and AFRICOS team in planning, implementing, monitoring, and evaluating study activities.
- Assist in developing research protocols, study tools, Standard Operating Procedures (SOPs), training materials, checklists, study logs, budget amendments, and IRB submissions in line with ICH-GCP standards.
- Ensure all research activities strictly adhere to approved protocols, Good Clinical Practice (GCP), GLP, ethical standards, and regulatory requirements.
2. Data Management, QA/QC & Routine Audits
- Oversee the collection, abstraction, entry, validation, and management of data across multiple program and research sources.
- Conduct routine quality checks to verify the completeness, accuracy, consistency, and integrity of research data.
- Coordinate data abstraction from patient records, laboratory reports, clinical databases, and programmatic information systems.
- Resolve data discrepancies, support corrective actions, maintain data quality assurance procedures, and ensure the secure, confidential storage of research records.
3. Laboratory QA/QC & Participant Follow-Up
- Support laboratory research activities in accordance with established protocols and GLP requirements, collaborating with laboratory personnel to ensure assay accuracy and monitor quality control processes.
- Support participant retention strategies to minimize loss to follow-up while maintaining effective communication, participant rights, and confidentiality.
- Maintain accurate, complete, and audit-ready participant files, complete data queries, and perform additional clinical duties as assigned by the Study PI or Senior Research and Evaluation Advisor.
Qualifications & Requirements
Education & Certifications
- A Bachelor of Science Degree in a Laboratory or Research Science-related field.
- Strong knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and research ethics.
Experience
- Minimum of 3 years of experience in clinical research.
- Demonstrated experience serving as a Sub-Investigator or equivalent role in clinical research studies.
- Proven experience working with HIV/AIDS clinical programs, research projects, participant recruitment, informed consent procedures, and follow-up.
- In-depth understanding of Care and Treatment Clinics (CTC), IRB approvals, protocol reviews, clinical research ethics, clinical laboratory science, quality management systems, and accreditation standards.
Core Skills & Competencies
- Proficiency in statistical and analytical software.
- Fluency in both English and Kiswahili.
- Exceptional analytical, problem-solving, organizational, and multitasking abilities under high-pressure environments and minimum supervision.
- Strong interpersonal, diplomatic, and multi-stakeholder relationship management skills, coupled with high integrity, confidentiality, and professional judgment.
How to Apply
Interested and qualified candidates should submit their applications online through the official HJFMRI Careers portal before the deadline:
(Note: Ensure your updated CV and supporting documents are ready before completing your online submission).