Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)

Job description

Job Description Summary :

Hours : 35 hours / week; 8 : 00 am -4 : 00 pm Monday-Friday

Status : Full Time

Level : 2 Years Experience

Education & Qualifications :

At minimum, completion of a Bachelor of Science degree or recognized equivalent

Fluency in French is an asset.

Duties & Responsibilities :

The Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist) supports the development, coordination, and oversight of CMRG-sponsored clinical research from protocol development through activation, follow-up, and close-out. Key responsibilities include but are not limited to :

• Contribute to protocol development, drafting, and amendments
• Coordinate study activities across single- and multicentre trials to support timelines and deliverables
• Support regulatory compliance, including Health Canada submissions (e.g., CTA / NOL), amendments, reporting, documentation and trial master file management.
• Ensure trials are conducted in accordance with ICH-GCP, Health Canada, FDA, US Federal Code, and applicable institutional policies
• Support study management activities, including tracking milestones and deliverables
• Assist with clinical trial monitoring according to established plans and SOPs
• Participate in clinical database and eCRF development, testing, maintenance, and lock
• Perform data review, data cleaning, and query management to ensure accuracy and completeness
• Maintain trial master files, regulatory documentation, and data management files
• Communicate effectively with sites, investigators, sponsors, and internal teams
• Apply quality assurance procedures to support high-quality data collection and regulatory compliance
• Any other clinical research task assigned by the supervisor.

Skills & Competencies :

Professional Afflictions / Memberships

Ability to travel up to 70% required.

Industry

Employment Type

Full-time