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Job Summary
Under the supervision of the Compliance Group (CG) Team Leader, the incumbent will conduct quality control and assurance activities for clinical trials in North America, providing support to both the monitoring and audit programs of the Canadian Cancer Trials Group (CCTG), as required.
The Monitor/Auditor will also participate in other compliance activities including, but not limited to, involvement with the Centre Performance Index (CPI) and Online Information Organization Network (ONION), and participation on committees and training programs critical to compliance assurance. The incumbent will also participate in central office data review, assessment, and querying procedures as needed.
Job Description
KEY RESPONSIBILITIES:
• Apply an understanding of clinical trials methodology, data collection and analysis, and cancer biology diagnosis and treatment in order to contribute to the oversight and review of multi- centre clinical trials in cancer therapy and supportive care.
• Coordinate and participate in quality control and assurance activities with participating member centres (cancer treatment centres), vendors, and collaborators, as well as internal trial teams, in order to ensure compliance.
• Interpret findings and identify issues such as non-compliance or scientific misconduct and notify CCTG personnel as needed. Ensure appropriate corrective action is undertaken for any identified deficiencies.
• Coordinate and participate in external audits and/or regulatory inspections in support of the overall quality control and assurance program of the CCTG.
• Apply an understanding of the current computer systems and applications in clinical trials conduct to effectively conduct compliance activities (e.g. EDC Medidata Rave). Provide education to participating member centres during on-site reviews and liaise internally to ensure trial standards.
• Promote awareness and understanding of Good Clinical Practice and other appropriate compliance procedures and guidelines. Act as a representative of CCTG in interactions with member centres, while conducting on site monitoring visits.
• Delegate work to AMG Assistants and ensure its completeness and accuracy. Participate in the training and mentoring of new monitors/auditors and others.
REQUIRED QUALIFICATIONS:
• Master’s degree in Health Sciences or equivalent combination of education and experience in a medical, research or pharmaceutical setting.
• Minimum of 2-3 years relevant experience in one or more of the following: clinical research, clinical trial methodology, quality assurance, monitoring.
• Consideration may be given to an equivalent combination of education and experience.
SPECIAL
SKILLS:
• Respect diversity and promote inclusion in the…
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