Cancer Research Compliance Specialist

4 weeks ago

Kingston, Ontario, Canada Queen's University Full time

About Queen's University

Queen's University is a leading research-intensive institution in Canada, offering a unique student learning experience. Our diverse employment opportunities span various areas, including globally recognized research, faculty administration, engineering, construction, athletics, and corporate shared services.

We are committed to employment equity and diversity in the workplace, welcoming applications from individuals from equity-seeking groups, including women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with disabilities, and those who identify in the LGBTQ+ community.

Job Summary

The Cancer Research Monitor/Auditor will conduct quality control and assurance activities for clinical trials in North America, providing support to the Canadian Cancer Trials Group (CCTG). This role involves monitoring and audit programs, as well as participation in compliance activities, including the Centre Performance Index (CPI) and Online Information Organization Network (ONION).

Key Responsibilities:

  • Apply knowledge of clinical trials methodology, data collection, and analysis to oversee and review multi-centre clinical trials in cancer therapy and supportive care.
  • Coordinate and participate in quality control and assurance activities with member centres, vendors, and collaborators to ensure compliance.
  • Interpret findings, identify issues, and notify CCTG personnel as needed, ensuring appropriate corrective action is taken.
  • Coordinate and participate in external audits and regulatory inspections to support the overall quality control and assurance program.
  • Apply knowledge of current computer systems and applications in clinical trials conduct to effectively conduct compliance activities.
  • Promote awareness and understanding of Good Clinical Practice and other compliance procedures and guidelines.
  • Delegate work to AMG Assistants, ensure its completeness and accuracy, and participate in training and mentoring.

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 clinical research, clinical trial methodology, quality assurance, or monitoring.

Special Skills:

  • Respect diversity and promote inclusion in the workplace.
  • Excellent organizational skills.
  • Attention to detail.
  • Superior communication skills.
  • Ability to work independently and collaborate effectively with colleagues.
  • Ability to prioritize competing demands.
  • Proven problem-solving and analytical skills.
  • Understanding of IT systems capabilities, including electronic data capture systems.
  • Computer skills, including WORD, Excel, and Oracle.
  • Working knowledge of French is an asset.
  • Ability to travel in North America approximately 60% of the time.

Decision Making:

  • Interpret findings and identify issues, notifying CCTG personnel as needed.
  • Determine and ensure implementation of appropriate corrective action.
  • Independent assessment of workload priorities to integrate overall organization, day-to-day administration, and medical review of data and analyses.
  • Participate in ongoing review of CCTG SOPs to ensure optimal methods to assess compliance.
  • Oversee, delegate, and assess the quality of work of AMG Assistants.

Employment Equity and Accessibility Statement:

The University invites applications from all qualified individuals. Queen's is committed to employment equity and diversity in the workplace, welcoming applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and those who identify in the LGBTQ+ community.

The University provides support in its recruitment processes to applicants with disabilities, including accommodation that takes into account an applicant's accessibility needs.

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