Ethics Research Associate

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Job Summary

Reporting to the Ethics Team Leader (ETL) the Ethics Research Associate will work within a team-based structure to support the conduct of national international and cooperative oncology group multi-centre multi-modality clinical trials in cancer therapy prevention and supportive care. The Ethics Research Associate provides ethics expertise conducting the central ethics responsibilities of the Office of Compliance and Oversight (OCO) within the Canadian Cancer Trials Group (CCTG).

Job Description

KEY RESPONSIBILITIES:
Works within a team-based structure to provide ethics expertise by applying an understanding of clinical trial protocols and applicable regulations and guidance documents.
Functions as the central role in performing full reviews of centre consent forms in English and French coordinating responses to centre queries and Research Ethics Board (REB) provisos in consultation with CCTG Study Coordinators and the Pharmacovigilance Team.
Works collaboratively with trial teams and the ETL in determining whether centre consent forms adequately include necessary ethical and regulatory elements and accurate protocol information re-reviewing as required to ensure compliance.
Reviews REB documentation and corresponds with centres as necessary before activation and for the duration of the trial.
Maintains electronic trial and centre files by ensuring complete and current information is on file including REB documentation consent documents and interpretation logs.
Updates information in Oracle-based ethics databases in a timely manner.
Provides regulatory-required documentation to Health Canada and to partner organizations as required prior to centre activation and for the duration of the trial.
Responsible for answering ethics-related questions received from internal and external partners.
Reviews instances where consent information at the time of enrollment generates a system flag addressing re-consent requirements with centre staff.
Prepares pre-visit assessments and consent form required elements checklists prior to monitoring visits and requests outstanding documents from centres following visit completion.
Attends regular meetings as an ethics representative and drafts notifications to be provided to centres.
Provides support to the OCO Manager and ETL and undertakes additional duties as assigned.

REQUIRED QUALIFICATIONS:
University degree in Health Sciences or relevant field.
Minimum 3 years relevant experience in a policy analysis regulatory or similar setting.
Previous experience in general research and writing analyzing/implementing policy ethics submissions medical writing and oral and written presentations are considered an asset.
Consideration may be given to an equivalent combination of education and experience.


SPECIAL SKILLS:
Respects diversity and promotes inclusion in the workplace.
Strong analytic abilities and research/writing experience.
Excellent attention to detail.
Must be highly organized with the ability to prioritize workload.
Ability to work well under pressure and independently.
Strong interpersonal and communicative skills.
Excellent working knowledge of applicable regulations and guidelines such as ICH-GCP and TCPS.
Understanding of department operations and functional objectives or an equivalent combination of training and experience.
Ability to work with confidential information.
Strong computer skills including Microsoft Word PowerPoint Excel and Oracle.

DECISION MAKING:
Prioritize work multi-task work within confines of strict deadlines.
Answer inquiries regarding implementation of policies and regulations and/or direct to appropriate sources/resources.
Determine appropriate documentation required for REB submissions.
Research relevant topics policies legislation determining context of documents.

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 .