Aurum’s projects and programmes cover a wide range of activities from programmatic implementation and technical assistance for HIV/AIDS and TB prevention, care and treatment services throughout the health system in South Africa, HIV prevention clinical research studies, TB and HIV vaccine studies, voluntary medical male circumcision to large scale TB preve...
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Conducting in-house monitoring to ensure compliance with ICH/GCP, standards, Protocol and other Guidelines as applicable.
Ensure that all staff are using current versions of Study documents, e.g. Protocol specific documents, program specific documents.
Data verification of source data and relevant documents e.g. CRF’s, and other data collection forms.
Give ongoing feedback on type of findings/trends etc.
Identify training needs in, and give feedback to the relevant Study Coordinator/Project Manager.
Developing and maintaining systems to ensure that correct data is collected by relevant staff
Raising study related queries with the Quality Manager, Principal Investigator, Project Manager and Study Coordinator to ensure clean and accurate data
Review project developed source documentation.
Provide training on quality related topics.
Prepare for monitoring visits
SOP review and writing as applicable
Review corrective/preventive actions
Assisting the Quality Manager in implementing the Quality Management Plan
Performing other duties as delegated by the Quality Manager
Ensuring version control of study documents
Ensuring timely reporting of all project activities using predefined indicators
Performing quality control of recording and reporting procedures including checking data collection tools for accuracy
Apply national and International legislation(s) pertaining to research
Ability to generate reports from Excel Data
Conducting QC1, QC2 and data verification activities
Requirements
Education:
Relevant degree/diploma in Health, Sciences or Social Sciences or equivalent education
Valid GCP certificate
Work Experience:
At least 2 years clinical research experience
Clinical or research experience
Previous work experience in a quality assurance/control environment advantageous
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