Research Ethics Specialist

The Ethics Specialist, in collaboration with the HiREB Manager and HiREB, is responsible for providing expert-level support for the ongoing development and improvement of the HiREB ethical review procedures. This includes (but is not limited to):

• Establishing a training program for new and ongoing REB members;

• Creating and maintaining educational materials, training sessions, guidelines and templates for research ethics personnel and researchers submitting to the Hamilton Integrated Research Ethics Board;

• Liaising with HiREB’s affiliated institutions to provide guidance on institutional initiatives that require engagement with HiREB;

• Establishing continuous quality improvement procedures for HiREB, and for researchers submitting to HiREB;

• Identification of new or emerging ethical challenges or needs;

• Developing policies, procedures and other materials, and

• Supporting implementation and ongoing improvement of local, provincial and national streamlined research ethics review initiatives

Additionally, when appropriately trained, qualified and delegated the authority to, the Ethics Specialist shall:

• Collaborate with the HiREB Chair(s)/Vice-Chair(s) on determining whether a project is research requiring REB review;

• Respond to complaints or concerns from participants and others about research projects, reviewing related files and establishing action plans as applicable/appropriate;

• Conduct ethical reviews of REB applications on behalf of the HiREB, make ethical determinations and provide approval when the requirements are met.

The incumbent will be working on problems of a diverse scope where analysis of data requires evaluation of identifiable factors. Conducting assessments and reviews requires the application of knowledge of ethical guidelines, provincial, national and international regulations, research guidelines and continuous quality improvement to evolve operational efficiencies and standardize processes. The Ethics Specialist identifies risks to the HiREB Manager and advises on corrective and preventative actions. Works with minimal supervision.

• Bachelor’s degree in health related field (or other academic field reviewed by HiREB) or equivalent; Master’s preferred;

• Minimum (4) years’ experience working in research or research ethics board setting in an academic institution/hospital

• Minimum five (5) years ethics and/or clinical research experience e.g., working with or at a Research Ethics Board, acting as a research coordinator, research program manager or clinical trials monitor

• Demonstrated knowledge of privacy and research ethics regulations, policies and guidelines associated with the ethical conduct of research involving human participants, including but not limited to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), Personal Health Information Protection Act (PHIPA), Freedom of Information and Protection of Privacy Act (FIPPA), Good Clinical Practice Guidelines, US FDA and Common Rule regulations related to research and Health Canada requirements (e.g., Food and Drugs Act and applicable regulations)

• Competency with medical and scientific terminology to a level which allows the discussion and recording of medical research issues and preparing correspondence, reports and summaries of medical studies

• Systematic thinker with strong project management and organizational skills

• Demonstrated ability to express complex technical concepts effectively

• Experience teaching and mentoring adults

• Strong interdisciplinary and team building skills

• Excellent judgement, tact and diplomacy

• Excellent verbal and written communication skills

• Exceptional external stakeholder and cross-departmental customer relations

• Strong analytical skills with particular attention to detail

• Demonstrated ability to prioritize workload and perform multiple concurrent tasks

• A high degree of motivation and self-directedness

• Strong technical writing skills (procedures, protocols, and reports)

• Strong skills with Word, Access, PowerPoint and Excel

Assets:

• Knowledge and/or experience working with Clinical Trials Ontario (CTO) preferred