Quality Control Officer (Pretoria) at The Aurum Institute

Description

• 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
• Proficiency in written and spoken English