Ethics Research Associate
5 months ago
Ethics Research Associate
About Queen's University
Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.
Come work with us
Job Summary
Reporting to the Team Leader, Ethics and Regulatory, the Ethics Research Associate will assist to conduct the ethics responsibilities of the Ethics and Regulatory (ER) office, within the Canadian Cancer Trials Group (CCTG).
**Job Description**:
**KEY RESPONSIBILITIES**:
- Reviews trial sample consent forms for necessary regulatory elements and appropriate lay language.
- Reviews ethics documentation and consent forms for all centres being activated on CCTG trials. Review ethics reminders prior to their quarterly distribution to centres and addresses central office and centre concerns/queries regarding ethics reminders.
- Corresponds with centres as necessary to request clarifications or additional information on Research Ethics Board (REB) documentation before activation. Communicates with centres regarding outstanding/inappropriate REB documentation in follow up to audit visits.
- Maintains centre files by ensuring complete and current information is on file regarding REB documentation. Updates information in centres and ethics databases, as required.
- Assists trial teams in determining whether centre prepared consent forms adequately include necessary ethical and regulatory elements. Assists trial teams by answering routine questions regarding level of ethics review required and acceptability of ethics documentation received from centres.
- Conducts periodic audits of in-house ethics documentation to ensure that staff understand and appropriately use the database. Reviews ethics documentation and consents in preparation for Quality Assurance audits.
- Organizes and participates in both internal training for ethics policies and procedures and external meetings of the Clinical Research Associate (CRA) ER Subcommittee of the CCTG CRA Committee.
- Provides general administrative assistance to the ER Manager and other members of the ER team. 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.
- 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 ethics assurance submissions.
- Research relevant topics, policies, legislation, determining context of documents.
Employment Equity and Accessibility Statement
**Skills**
**Reference**
- 337206
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