Openings at South African Medical Research Council

Responsibilities

• To conduct laboratory processes in compliance with local and international regulations i.e: SANAS, SA GCP, DAIDS Good Clinical Laboratory Practice (GCLP)
• To conduct laboratory duties at the clinical research site laboratory (CRSL) and Central Routine Laboratory (CRL)
• Processing of samples as per SOP, protocol and GCLP during the pre-analytical, analytical and post analytical stages
• To provide accurate, precise and quality results within stipulated turnaround times
• Adhere to the internal and external quality control and quality assurance programs
• Management of onsite/central laboratory stock
• Management of laboratory documentation at the onsite laboratory/central laboratory
• Train, mentor and assess new laboratory staff
• Perform validations, verifications and proficiency/competency testing
• Prepare weekly and monthly technical reports
• Preparation of the laboratory for audits
• Be willing to work at all HPRU site laboratories, Central Routine/Research Laboratory and other areas of laboratory as needed.
• Be willing to work on prevention studies, treatment studies and COVID-19 studies.

Core Requirements

• National Diploma - Biomedical Technology or similar relevant qualification or higher
• 1- year experience in a Clinical Pathology laboratory, post qualification
• Proof of current registration with the Health Professions Council of SA in Clinical Pathology Independent Practice
• Willing to work outside normal working hours, i.e. afterhours and weekends

Advantageous

• Good Clinical Laboratory Practice [GCLP], International Air Transport Association (IATA) training
• Previous research/clinical trial experience
• Ability to multitask and work under pressure
• A Code 8 driver’s license

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Responsibilities

• Internal monitoring of clinical trial data using approved protocols and standard operating procedures as per the clinical quality management plan
• Review 100% informed consent forms and locators
• Submit internal monitoring reports timeously and debrief study investigators and site staff on common findings and trends
• Assist with preparation for external audits and monitoring
• Review study related regulatory documentation including local ethics, SAHPRA and sponsor correspondence.

Core Requirements

• A relevant 3-year degree in Health/Social Science or similar relevant qualification or higher
• At least 3 years clinical research experience
• At least 1-2 years’ experience with quality assurance activities in clinical trials

Advantageous

• Valid code 8 driver’s license
• Valid recent GCP and HSP certificate
• Willingness to work outside normal working hours when required
• Work with meticulous attention to detail to ensure good data quality
• Effective organizational, communication and interpersonal skills
• Excellent computer skills in MS Office packages
• The ability to maintain a high degree of professionalism and confidentiality
• The ability to work independently, under pressure and honor deadlines.