Jobafrican
Website University of Cape Town
Job Description:
This position requires will be to carry out aspects of quality assurance, including auditing study team compliance with required study procedures and Good Clinical Practice standards in order to verify that all research guidelines and regulations are adhered to
Job Responsibilities:
- Perform source document verification in accordance to protocol needs and Quality
- For completeness and accuracy and ensure that corrections are made appropriately.
- Verify study conduct in accordance with site SOP’s, Study SSP’s and protocol
- management plan.
- Review Case Report Forms (CRFs) and Electronic Data Completion (EDC)
- Review and report outstanding issues at the site, for example Serious Adverse Events (SAEs), adherence to protocol and data quality issues.
- Adherence to RSA and ICH GCP by sites in conducting studies
Job Requirements:
- Matric with a tertiary qualification in a Health related field or relevant
- Experience in using Databases e.g. Imedidata
- Knowledge of Good Clinical Practice (GCP) guidelines and clinical trial site processes
- Thorough understanding of RSA/ICH GCP
- Atleast 1-2 years’ experience conducting internal monitoring/quality assurance
- Working Knowledge of procedural document such as SOP’s, SSP’S and MOP
Job Details:
Company: University of Cape Town
Vacancy Type: Full Time
Job Functions: N/A
Job Location: Cape Town, Western Cape, SA
Application Deadline: N/A
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