Ethics Team Leader

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Job Summary

Reporting to the Manager Office of Compliance and Oversight the Ethics Team Leader will lead the Ethics Team at the Canadian Cancer Trials Group (CCTG) within the OCO. The core responsibilities include leadership to ensure compliance with national and international regulations and guidelines applicable to clinical trials development and implementation of Standard Operating Procedures at the Operations and Statistics Centre and across the CCTG network and providing guidance in alignment with CCTG strategic directions. The Ethics Team Leader will lead and supervise staff to coordinate and facilitate ethics processes essential to the successful oversight clinical trials.

Job Description

KEY RESPONSIBILITIES:
Lead the research ethics area of the CCTG. Responsible for the following:
oProvide expert knowledge and application of national and international clinical trial regulations and guidelines as they pertain to research ethics. Provide leadership to ensure Group is proactive and current with relevant regulations and guidelines.
oParticipate in national and international initiatives on behalf of CCTG (e.g. Informed Consent Harmonization).
oEnsure privacy of research subjects through development and implementation of processes required to manage requirements as well as resolution of any issues arising.
oReview protocols to ensure that they are consistent with current policies procedures regulations and guidelines.
oProvide leadership to the development and maintenance of the generic CCTG Informed Consent (IC) forms in accordance with all required regulations and guidelines. This includes review of generic trial Informed Consent (IC) forms in accordance with required regulations and guidelines and in accordance with the requirements of the clinical trial prior to regulatory submission and at amendment time points in addition to local informed consent review.
oProvide expert knowledge of local/provincial ethics review and oversight procedures. Review of local centre submission and approval documentation to ensure compliance in addition to timely start up. Define and oversee expectations with respect to ethics documentation reviews and appropriate levels of review when questions from OCO team arise.
oEnsure CCTG databases capture information required to ensure compliance. Develop processes to ensure oversight and address issues with participating sties/groups.

Develop and implement key Standard Operating Procedures (SOPs) and Work Instructions to deliver quality and ensure consistency across all team members within the ethics program.
Develop training materials and evaluations for new quality initiatives and oversee the training and education of ethics team and the CCTG network.
Develop and implement tools to increase quality and efficiency within the ethics team. Manage quality and efficiency by effectively motivating monitoring and managing team performance with regards to efficiency and quality.
Leadership and supervision of team members to ensure Group goals are met in compliance with applicable national and international regulations and guidelines.
oLead ethics staff in review processing tracking monitoring of ethics documents to ensure compliance with CCTG standard operating procedures.
oProvide support expert advice and facilitate process development including implementation and training.
oDelegate work of the team ensure quality control and quality assurance activities are conducted and manage metrics/timelines required in line with the Groups strategic agenda projects and trials.
oProvides day-to-day supervision to staff in the unit. Reviews assignments and provides feedback on work to employees. Provides coaching and feedback on work quality issues. Escalates unresolved performance and/or disciplinary matters to OCO Manager.
Perform other duties as assigned. Supports the ethics operational function as required.

REQUIRED QUALIFICATIONS:
Masters degree in Health Sciences or equivalent combination of education and experience in a medical research or regulatory setting.
Minimum of 5 years relevant experience in one or more of the following: clinical research health sciences health policy ethics or regulatory field.
Expert understanding and experience interpreting and implementing regulations pertaining to national/international clinical trials. Experience in ethical review of research and informed consent development.
Understanding of privacy legislation and management of significant findings andglobal understanding of ethical requirements (e.g. EU Directive) is considered an asset.
Experience supervising and leading employees.
Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:
Respects diversity and promotes inclusion in the workplace.
Expertise in regulations and guidelines governing clinical trials.
Leadership and supervisory skills.
Ability to work collaboratively within a team and across functional groups as well as have the ability to work independently.
Proven problem solving and analytical skills.
Excellent attention to detail.

Must be highly organized with the ability to prioritize workload.
Ability to work well under pressure and multi-task in a changing environment.
Strong communication and interpersonal skills.
Ability to critically and accurately review and interpret medical information.
Ability to make formal presentations and represent the Group at professional meetings.
Computer skills including Word Excel PowerPoint knowledge of database structures (e.g. Oracle Web Based Systems Electronic Data Capture systems Clinical Trial Management Systems).
Ability to work with confidential information.
Working knowledge of French an asset.

DECISION MAKING:
Determine effective communication processes (across teams departments centres etc.).
Delegate work to team members and ensure its accuracy.
Determine priorities and make decisions about staff utilization and the assignment of work to achieve optimum efficiencies and productivity.
Monitor and assess output and the quality of employees work and recommend need for formal training or development plans to management and identifies possible staff performance and/or disciplinary issues.
Review variations in ethics processes and documentation to determine whether the Group and national/international requirements have been met.
Review trial initial/amended ICs as well as local ICs to ensure compliance with CCTG SOPs and applicable regulations and guidelines. Determine if processes are appropriate and if required elements are sufficiently addressed.
Review amendments/administrative updates to determine the appropriate level of review for sites and whether the instructions regarding the required level of Research Ethics Board (REB) approval and patient re-consent are clear sufficient and compliant with applicable regulations.
Provide guidance and support on privacy related issues.

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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.

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