Quality Control Officer - Rustenburg, South Africa - The Aurum Institute

The Aurum Institute

Verified Company

Rustenburg, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

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/WPG 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
Ability to generate reports from Excel Data
Conducting QC1, QC2 and data verification activities

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

Other: