This position will require the candidate to carry out aspects of quality control and assurance, including monitoring and auditing study site and team compliance with required study procedures and Good Clinical Practice standards in order to verify that all research guidelines and regulations are adhered to.

Requirements

• Matric with a tertiary qualification in a Health-related field
• At least 2-4 years’ working experience in a Clinical/Research environment
• At least 2-3 years’ experience conducting internal monitoring/quality assurance/quality control
• Experience in using Databases e.g. Imedidata
• Valid SA Good Clinical Practice (GCP) certificate
• Valid Driver’s license
• Knowledge of Sponsor/Funder principles and guidelines, e.g. DAIDS
• Working Knowledge of procedural document such as Standard Operating Procedure (SOP), Study Specific Procedures (SSP) and Manual of Operational Procedures (MOP)
• In depth knowledge and understanding of Good Clinical Practice (GCP) guidelines, SA GCP as well as clinical trial site processes
• In depth understanding and knowledge of Regulatory and Ethics Guidelines
• Strong written and verbal proficiency in English
• Strong client focus
• Excellent ability to build interpersonal relationships and partnerships
• Strong problem-solving and decision-making abilities
• Ability to work under pressure
• Ability to work independently
• Strong attention to detail
• Excellent planning and organising skills
• Willingness to travel to sites locally

Responsibilities:

• Assist by providing input regarding clinical quality management plan development and implementation, in line with NIH DAIDS Clinical Quality Management Plan and other requirements by funders and regulators
• Review all the HREC and SHAPRA approvals and communication to ensure that all applicable approvals and notifications are in place
• Follow the monitoring plan for the study, site and or DTHF
• Log and review protocol deviations and suggest corrective and preventative actions
• Ensure corrective action is implemented timeously
• Perform source document review and verification in accordance with SA/ GCP, protocol and Quality management plan
• Review Case Report Forms (CRFs) and Electronic Data Capture (EDC), for completeness and accuracy ( ALCOA + principals) and ensure that corrections are made appropriately
• Review and report outstanding issues at the site, for example Serious Adverse Events (SAEs), adherence to protocol and data quality issues
• Compliance verification to approved study protocol
• Adherence to SA GCP and ICH GCP by sites in conducting studies
• Verify study conduct in accordance with site SOP’s, Study SSP’s and protocol