IDRC
Job Requirements/Responsibilities:
- Receive, accession, and verify biological specimens from study participants against study request forms and enrolment trackers.
- Process specimens according to study SOPs and assay-specific requirements, including centrifugation, aliquoting, labelling, and storage at the appropriate temperatures.
- Maintain specimen logs and ensure full chain-of-custody traceability from receipt through testing, storage, and shipment.
- Coordinate specimen shipment to reference or partner laboratories, preparing shipping manifests and relevant documentation, and managing cold chain requirements.
- Dispose of biological waste appropriately in accordance with IDRC/KDxL biosafety protocols and applicable national guidelines.
- Perform both novel and reference HIV viral load and CD4 tests on study specimens in accordance with study SOPs and manufacturer instructions, following any training provided by product developers.
- Carry out additional assays as required by the study protocol, which may include haematology, biochemistry, sputum smear microscopy, molecular diagnostic assays, and other relevant tests.
- Operate, calibrate, and maintain laboratory instruments and point-of-care platforms, performing troubleshooting and preventive maintenance per manufacturer and IDRC protocols.
- Review and validate test results prior to release; investigate and escalate discrepant, invalid, or out-of-range results to the Laboratory Manager.
- Implement blinding procedures as specified in the study protocol to minimise interpretation bias.
- Set up testing environments for healthcare worker and laboratory personnel participants during study usability assessment sessions.
- Provide standardised test training to usability assessment participants and assist with structured observation checklists during sessions.
- Document task performance metrics during usability assessments as directed.
- Record all test results accurately in paper worksheets and enter data into the REDCap electronic data capture platform using participant study numbers.
- Maintain up-to-date laboratory worksheets, instrument printouts, QC logs, reagent inventory records, and temperature logs.
- Review data for completeness and accuracy; resolve data queries in coordination with the Study Coordinator and data management team.
- Prepare and disseminate bi-weekly laboratory monitoring reports to relevant stakeholders, ensuring accuracy, completeness, and timely submission.
- Implement and maintain the laboratory Quality Management System in accordance with ISO 15189:2022 requirements and GCLP standards.
- Perform daily, weekly, and monthly equipment quality control, calibration, and preventive maintenance procedures, documenting all findings.
- Participate in internal and external quality assurance and proficiency testing programmes, including enrolment, testing, and documentation of results.
- Develop, implement, and periodically review laboratory standard operating procedures (SOPs) in consultation with the Laboratory Manager.
- Identify non-conformances, investigate root causes, and implement corrective and preventive actions (CAPA) in coordination with the Laboratory Manager.
- Adhere to biosafety and biosecurity protocols for all laboratory activities in accordance with ISO 15190 and applicable national and institutional safety regulations; always use appropriate personal protective equipment (PPE).
- Maintain accurate inventory of reagents, consumables, and laboratory supplies; proactively raise requisitions to prevent stock-outs, verifying expiry dates, batch numbers, and storage conditions upon receipt.
- Coordinate scheduled maintenance and equipment repairs with the Laboratory Manager to ensure continuity of workflow.
- Liaise with the clinical study team regarding specimen schedules, critical results, and participant safety-related laboratory findings.
- Communicate with locally and internationally based study investigators as required, including participation in regular conference calls.
- Conduct orientation, training, and mentorship of new laboratory personnel on workflows, SOPs, and best practices.
- Support preparation for sponsor monitoring visits, audits, and IRB/regulatory inspections; maintain organised, current laboratory documentation.
- Perform any other duties as assigned by your supervisor. Duties may be revised to reflect the evolving needs of the study; you will always be consulted in advance of such changes.
Qualifications:
- BACHELORS : Bachelor’s in Medical Laboratory Science or Biomedical Laboratory Technology or equivalent qualification from a recognized institution – Mandatory
- DIPLOMA : Diploma in Medical Laboratory Science or Biomedical Laboratory Technology or equivalent qualification from a recognised institution may be considered for candidates with substantial research laboratory experience. – Optional
Certifications:
- Valid practicing licence from the Allied Health Professionals Council (AHPC). – Mandatory
- Valid GCP and/or Good Clinical Laboratory Practice (GCLP) – Mandatory
Skill & Experience:
- Demonstrated competency in sample collection, processing, analysis, and result reporting in the context of HIV and/or TB diagnostics – Mandatory
- Knowledge of ISO 15189:2022 requirements, laboratory quality management systems, and laboratory biosafety standards (ISO 15190). – Mandatory
- Experience or knowledge of molecular and immunology diagnostic techniques e.g., PCR-based assays and related laboratory procedures. – Added Advantage
- Experience with Laboratory Information Systems (LIS) and electronic data capture platforms (e.g., REDCap) is an added advantage. – Mandatory
- Ability to work flexibly and collaboratively within multidisciplinary and multi-site research teams. – Mandatory
- Proficiency in basic computer applications (Microsoft Word, Excel, Outlook). – Added Advantage
- Experience in a clinical or research laboratory setting – Mandatory
- Ability to design and implement analytical experiments – Added Advantage
Deadline: 16/02/2026
