Quality Control Officer

2 weeks ago


Rustenburg, North-West, South Africa The Aurum Institute Full time
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:

  • Valid Driver's license
  • Own transport advantageous
  • Ability to work independently and in a team
  • Open and clear communicator
  • Focused on quality and detail
  • Working Knowledge of MS Packages
  • Data Analysis Skills

Closing date: 12 April 2024

Please Note:
Kindly provide current and relevant references for background checks
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