Quality Control Reviewer - Clinical Trials

Cliantha Research - Mississauga, ON (28 days ago)

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General Responsibilities:

  • Handles tasks under direction and guidance
  • Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
  • Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha SOPs and study protocols
  • Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
  • Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
  • As required, follow-up on all QC findings, until a satisfactory resolution has been determined
  • Assure documentation review meets or exceeds designated timeline parameters
  • Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
  • Ensuring training file and SOP reading is maintained and up to date
  • Ensure compliance with appropriate Cliantha SOP’s, GCP and ICH guidelines
  • Participate in training sessions
  • Participate in training of staff as experience and qualifications permit
  • Work in a safe manner that does not endanger yourself or co-workers
  • Execute other duties as may be required by the QC Manager and other members of Cliantha Research Management team as training and experience allow

General Responsibilities:

  • Handles tasks under direction and guidance
  • Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
  • Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha SOPs and study protocols
  • Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
  • Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
  • As required, follow-up on all QC findings, until a satisfactory resolution has been determined
  • Assure documentation review meets or exceeds designated timeline parameters
  • Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
  • Ensuring training file and SOP reading is maintained and up to date
  • Ensure compliance with appropriate Cliantha SOP’s, GCP and ICH guidelines
  • Participate in training sessions
  • Participate in training of staff as experience and qualifications permit
  • Work in a safe manner that does not endanger yourself or co-workers
  • Execute other duties as may be required by the QC Manager and other members of Cliantha Research Management team as training and experience allow

Job Type: Part-time