Cancer Research Compliance Specialist

7 hours ago

Kingston, Ontario, Canada Queen's University Full time

About Queen's University

Queen's University is a leading research-intensive institution that offers a unique student learning experience. Our diverse employment opportunities span multiple areas, including globally recognized research, faculty administration, engineering and construction, athletics and recreation, power generation, and corporate shared services.

We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity-seeking groups, including women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with disabilities, and persons 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 will involve 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, and cancer biology diagnosis and treatment to oversee and review multi-centre clinical trials.
  • Coordinate and participate in quality control and assurance activities with participating member centres, vendors, and collaborators to ensure compliance.
  • Interpret findings and identify issues such as non-compliance or scientific misconduct, and notify CCTG personnel as needed.
  • Coordinate and participate in external audits and/or regulatory inspections to support the overall quality control and assurance program of the CCTG.
  • 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 and ensure its completeness and accuracy.

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.

Special Skills:

  • 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 with colleagues.
  • Ability to prioritize competing demands.
  • Ability to learn new skills.
  • Proactive, consultative, and collaborative.
  • Proven problem-solving and analytical skills.
  • Understanding of IT systems capabilities.
  • Computer skills including WORD, Excel, Oracle.
  • Working knowledge of French is an asset.
  • Ability to travel in North America approximately 60% time.

Decision Making:

  • Interpret findings and identify issues such as non-compliance or scientific misconduct and notify CCTG personnel as needed.
  • Determine and ensure implementation of appropriate corrective action required to resolve any identified deficiencies.
  • Independent, ongoing assessment of workload priorities is essential to integrate the overall organization, day-to-day administration, and medical review of data and analyses of many trials.
  • Participate in ongoing review of CCTG SOPs to ensure optimal methods to assess compliance are in place, assure consistency across Compliance.
  • Oversee, delegate and assess the quality of work of the AMG Assistants, and recommends need for formal training or development plans and identifies possible staff performance and/or disciplinary issues to Team Leader.

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 and welcomes applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and persons of any sexual orientation or gender identity. In accordance with Canadian Immigration requirements, priority will be given to Canadian citizens and permanent residents.

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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