New job Research Ethics Administrator in Quebec
Research Ethics Administrator
Company : McGill University
Salary : $51,190 - $76,770 a year
Location : Quebec
The Research Ethics Administrator (REA) works alongside the Research Ethics Officer throughout the ethics review process of the clinical research. The REA advises researchers and study coordinators on appropriate practices pertaining to clinical research ethics, manages ethics applications to the MUHC Research Ethics Board (REB) and other relevant ethics boards, and ensures administrative and regulatory compliance for clinical research projects. The REA reviews and edits documents, such as informed consent forms, and makes recommendations to sponsors regarding Quebec and Canadian regulatory requirements. The REA also assists with the flow of all documents that require submission to the REB.
1. Provide effective administrative leadership for research ethics activities.
2. Ensure administrative compliance with the practices of McGill University and the McGill University Health Centre, and of industry partners and granting agencies.
3. Prepare, update, and maintain applicable industry and government regulatory documentation according to Canadian and applicable US standards.
4. Provide expertise and advice to researchers and study coordinators on the preparation of ethics applications and liaise with sponsors regarding their policies and practices. Provide interpretation of regulatory agencies' rules and regulations, and University policies and procedures. Implement new policies and new initiatives to support the research program. Keep abreast of regulations and new developments; inform appropriate staff members accordingly.
5. Liaise with the MUHC Research Ethics Board, the MNI Magnetic Resonance Research Committee, researchers, study coordinators, and study sponsors in order to coordinate activities and to ensure that there is adequate communication between all parties.
6. Keep up-to-date on the Quebec government multicentre mechanism, and communicate with other participating research centres to the extent that it requires. Liaise with sponsors and non-MUHC researchers to initiate clinical trials under the multicentre mechanism.
7. Interface with the NAGANO research ethics platform. Instruct staff members on the relevant
features of the platform.
8. Help to improve Unit efficiency by recommending changes to the Unit's internal procedures, and implementing decisions made by the CRU's senior management team as they relate to the ethics review process.
9. Create, prepare, and/or modify consent forms, brochures, and advertising for industry and investigator-initiated research projects.
10. Prepare and make ethics submissions, including initial applications, amendments, safety reports, and updates. Ensure that safety reports are reviewed and signed by researchers in a timely manner.
11. Undertake special projects as required.
12. The REA is responsible for the completion of ethics-related projects and tasks that have been delegated to them by the Research Ethics Officer.
Other Qualifying Skills and/or Abilities
Undergraduate degree preferred (B.Sc. or B.A.). Previous research ethics experience and knowledge of the MSSS ethics framework in clinical trials; knowledge of industry sponsored and grant funded clinical trials an asset; bilingualism, attention to details and high organizational skills required; p roficient in a PC environment, MS Office; proven ability to work effectively both independently and in a team-based environment; ability to work in a fast-paced environment, to carry out multiple projects within the same period, and to adapt and be flexible to changing circumstances.
Minimum Education and Experience:
Hours per Week:
Position End Date (If applicable):
Deadline to Apply:
McGill University hires on the basis of merit and is strongly committed to equity and diversity within its community. We welcome applications from racialized persons/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and persons of minority sexual orientations and gender identities, as well as from all qualified candidates with the skills and knowledge to productively engage with diverse communities. McGill implements an employment equity program and encourages members of designated groups to self-identify. Persons with disabilities who anticipate needing accommodations for any part of the application process may contact, in confidence, email@example.com or 514-398-3711.