Clinical Research Coordinator/ Regulatory Affairs (Research Institute)

McGill University Health Centre; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player in biomedical research is seeking a dedicated individual to support clinical research submissions. This role involves reviewing informed consent forms, collaborating with various stakeholders, and ensuring compliance with ethical standards. The successful candidate will play a crucial role in facilitating innovative medicine research while maintaining effective communication with sponsors and study teams. If you are passionate about advancing healthcare through research and thrive in a collaborative environment, this opportunity could be the perfect fit for you.

Qualifications

• Bachelor's degree in health sciences or a related field is preferred.
• Strong communication skills are essential for stakeholder management.

Responsibilities

• Support submission of clinical research studies to ethics committees.
• Review and revise informed consent forms to meet standards.
• Maintain communication with all stakeholders during submission processes.

Skills

Clinical Research Submission

Informed Consent Forms Review

Communication Skills

Stakeholder Management

Education

Bachelor's Degree in Health Sciences or related field

Tools

Nagano

Job description

RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position Summary
Under the supervision of the Supervisor, Clinical Research Administration Centre for Innovative Medicine (CIM), the incumbent is responsible for supporting the submission of clinical research studies to the Centre of Applied Ethics and other site-specific assessments.

General Duties

1. Review and revise sponsor’s informed consent forms to ensure they meet FRSQ standard approved language.
2. Work with sponsors and study teams to obtain all documents required to start submissions.
3. Submit studies through Nagano to reviewing committees (ethics and site-specific reviews).
4. Maintain ongoing communication with Ethics, Contracts, Investigators, and Sponsors during submission and renewal timelines to ensure that all needs are met.
5. Optimize study review time.
6. Serve as the primary point of contact for all stakeholders.
7. Conduct other related tasks as assigned by the supervisor.