Senior Research Technologist: Quality Assurance Officer - HIDRU - R 513B at South African Medical Research Council

The HIV and other Infectious Diseases Research Unit (HIDRU) seeks to appoint a Quality Assurance Officer to conduct internal monitoring at clinical research sites within the Durban region, to ensure compliance with SA and ICH GCP and HSP requirements. Quality assurance activities will include working within the framework of approved protocols and regulatory documentation. The Quality Assurance officer will work across multiple research projects including COVID-19 studies and work across multiple sites.

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.

Closing Date: 10th, July 2022