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SalaryCompetition Number: J0224-0944
Position Title:Audit & Monitoring Group (AMG) Team Leader
Position Number (Final): 00122846
Employee Group: Research, Grant & Contract
Job Category: Research
Department or Area: Canadian Cancer Trials Group
Location: Kingston, Ontario, Canada (Hybrid)
Salary: $71,767.00 - $89,050.00/Year
Grade: 09 Review Salary Information Here
Hours per Week: 35
Job Type: Term
Length of term: 5.5 months
Shift: 7 Monday - Friday
Number Of Positions: 1
Date Posted: March 1, 2024
Closing Date: March 17, 2024
COVID 19 On-Campus Requirements
Prior to May 1, 2022, the University required all students, faculty, staff, and visitors (including contractors) to declare their COVID-19 vaccination status and provide proof that they were fully vaccinated or had an approved accommodation to engage in in-person University activities. These requirements were suspended effective May 1, 2022, but the University may reinstate them at any point.
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Job Summary
Reporting to the Manager, Office of Compliance and Oversight (OCO), the Audit and Monitoring Group (AMG) Team Leader will lead one of the two teams in AMG, namely the Canadian On-Site Monitoring Team OR the Residual and International Monitoring Teams. The AMG Team Leader will ensure AMG standard operating procedures are followed to ensure compliance with applicable guidelines, regulations and standards. The incumbent will lead team staff to coordinate and implement monitoring and processes essential to the successful management of the respective clinical trials conducted by Canadian Cancer Trials Group (CCTG).
Job Description
KEY RESPONSIBILITIES:
• Lead one of the two teams in AMG with respect to monitoring of clinical sites to ensure compliance with internal standards and national regulations including Good Clinical Practice (GCP). Ensure compliance with clinical trials guidelines and regulations and to ensure standards are met. Update team methods, policies and train staff on changes affecting that team.
• Manage and coordinate the program of monitoring visits that the team is responsible for, to ensure the integrity of clinical data with respect to accuracy, documentation, methods or procedures and compliance with policies and regulations. Prepare and review monitoring reports. Report to the Manager OCO, Compliance Director and the Clinical Trials Monitoring Branch (CTMB), as applicable. Liaise closely with key teams such as CTMB and Trial Teams.
• Travel to cancer centres to perform on site monitoring visits. May participate in interactions with industry in regards to site compliance.
• Coordinate the activities of the AMG team including assisting with training. Plan, assign, delegate work of the team and ensure work is carried out appropriately.
• Provide work direction, and technical/functional guidance to AMG team staff. Schedule and assign work, and oversee its completion. Coordinate and monitor work flow.
• Schedule and approve, or recommend the approval of, employees' hours of work, overtime and absences. Monitor and oversee employee attendance.
• Participate in screening and interviewing job candidates, and providing input into staff selection.
• Review assignments and provide feedback on work to employees. Provide input on work performance to management staff.
• Provide orientation and on-the-job training to employees in the unit. Provide coaching and feedback on work quality issues, providing related day-to-day supervision. Escalate unresolved performance and/or disciplinary matters to the Manager, OCO.
• Undertakes additional duties in support of the AMG team and the CCTG.
REQUIRED QUALIFICATIONS:
• Master's degree in Health Sciences or equivalent program of study.
• Previous relevant experience (minimum of 5 years) in one or more of the following: clinical research, clinical trial methodology, quality assurance in a healthcare setting.
• Previous clinical trial monitoring experience, including hands-on experience with several clinical trial components (e.g. monitoring, clinical study management, report writing, contracts).
• In-depth knowledge, strong understanding and experience of regulations and their implementation (in particular ICH/GCP, TCPS, HC, FDA, CTEP, OHRP) pertaining to clinical trials in Canada is required.
• Consideration may be given to an equivalent combination of education and experience.
SPECIAL SKILLS:
• Respects diversity and promotes inclusion in the workplace.
• Leadership and supervisory skills to motivate staff and create a positive work environment.
• Ability to work collaboratively within a team and across functional groups, as well as have the ability to work independently.
• On-site monitoring/auditing experience or knowledge.
• Knowledge of the purpose, policies, standards and procedures involved in monitoring clinical trials.
• Interpersonal and communication skills (both verbal and written) to deal with a diverse group of individuals in a professional manner and ability to provide clear and accurate information.
• Project management experience and strong analytical, detail oriented and organized approach to work.
• Ability to critically and accurately review and interpret medical information.
• Ability to multi-task in a changing environment with the ability to prioritize workload.
• Ability to problem-solve and exercise discretion. Must have the ability to adhere to strict confidentiality; ability to recognize and handle confidential information in an appropriate manner.
• Must have influencing and negotiating skills.
• Ability to make formal presentations and represent Group at professional meetings.
• Computer skills including Word, Excel, PowerPoint, knowledge of database structures (preferably Oracle and Medidata RAVE).
• Ability to travel up to 40% time.
DECISION MAKING:
• Determine effective communication processes (across teams, departments, centres, etc.) and interface effectively with other AMG team members, as well as Trial Teams, CTMB and the Manager, OCO to maintain GCP compliance.
• Determine site visits required to ensure the integrity of clinical data and report to the OCO Manager.
• In collaboration with senior leadership, determine appropriate policies and procedures with respect to functions of the AMG Team and decide how modifications should be proposed and implemented.
• Provide recommendations on best alternatives to a given problem, identifying potential risks and benefits of each.
• Assess the suitability of job candidates and recommend the most appropriate person for hire.
• Determine priorities and make decisions about staff utilization and the assignment of work to achieve optimum efficiencies and productivity.
• Assess employees' training needs and make recommendations for internal or external training to attain proficiency.
• Monitor and assess output and the quality of employees' work, and recommend need for formal training or development plans to management and identify possible staff performance and/or disciplinary issues.
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. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at hradmin@queensu.ca.
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