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 with a commitment to transformative student learning experiences. We offer diverse employment opportunities across various areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and more.

We are dedicated 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 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) monitoring and audit programs. This role will also participate in other compliance activities, including the Centre Performance Index (CPI) and Online Information Organization Network (ONION), and contribute to committees and training programs critical to compliance assurance.

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 in cancer therapy and supportive care.
  • 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, and provide education to participating member centres during on-site reviews.
  • Promote awareness and understanding of Good Clinical Practice and other compliance procedures and guidelines, and act as a representative of CCTG in interactions with member centres.
  • Delegate work to AMG Assistants and ensure its completeness and accuracy, and participate in the training and mentoring of new monitors/auditors and others.

Required Qualifications:

  • Master's degree in Health Sciences or an 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 in a cooperative spirit with colleagues.
  • Ability to prioritize competing demands.
  • Ability/enthusiasm to learn new skills.
  • Proactive, consultative, and collaborative.
  • Proven problem-solving and analytical skills.
  • Understanding of IT systems capabilities, including evolving electronic data capture systems.
  • Computer skills, including WORD, Excel, 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 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 recommend 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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