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:

• Experience managing and monitoring oncology trials
• Experience in regulatory management and Health Canada submissions
• Experience in database development using  Medidata Rave and REDCap
• Demonstrated proficiency in English and French, with excellent oral and written communication skills
• Excellent organizational and prioritization skills, ability to learn quickly and independently
• Ability to work under pressure and attention to detail
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with CMRG standards
• Exercise initiative and good judgment with ability to multi-task
• Ability to work in a rapidly growing environment and able to quickly adapt to changes
• Knowledge of applicable legislative and regulatory policies.
• Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint).

Professional Afflictions/Memberships

• SoCRA or ACRP designation preferred.

Ability to travel up to 70% required.

Industry

• Research Services

Employment Type

Full-time