Website Queens University
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.
- Coordinate and participate in external audits and/or regulatory inspections in support of the overall quality control and assurance program of the CCTG.
- 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 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.
- 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.
- 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.
- Delegate work to AMG Assistants and ensure its completeness and accuracy. Participate in the training and mentoring of new monitors/auditors and others.
- 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.
- Respect diversity and promote inclusion in the workplace.
- Excellent organizational skills
- Attention to detail
- Superior communication skills both written and verbal
- Ability to work independently and liaise effectively in a cooperative spirit with colleagues both within the central office and across the country
- Ability to prioritize competing demands
- Ability/enthusiasm to learn new skills
Qualification & Experience:
- 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.
Company: Queens University
Vacancy Type: Full Time
Job Location: Ottawa, CA
Application Deadline: N/A