Cancer Research MonitorAuditor

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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:
Masters 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 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
Proactive consultative and collaborative
Proven problem solving and analytical skills
Understanding of IT systems capabilities including evolving electronic data capture systems (e.g. Medidata Rave)
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.
Oversees delegates and assesses 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. Queens is strongly committed to employment equity diversity and inclusion in the workplace and encourages applications from Black racialized persons Indigenous people women persons with disabilities and 2SLGBTQI accordance with Canadian Immigration requirements priority will be given to those who are legally eligible to work in Canada.

The University provides support in its recruitment processes to all applicants who require accommodation due to a protected ground under the Ontario Human Rights Code including those with disabilities. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at .