Clinical Regulatory Specialist: Start-up & Compliance

Centricity Research; Toronto; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading clinical research network is hiring a Regulatory Specialist in Toronto, Ontario. This full-time role involves preparing and submitting regulatory documents essential for clinical trials, ensuring compliance with regulations. Candidates should have 1-3 years of clinical research experience, strong organizational skills, and familiarity with ICH/GCP and FDA requirements. The role offers an opportunity to contribute to efficient trial processes and facilitate collaboration among various stakeholders. Join a mission-driven team dedicated to advancing scientific research while maintaining a focus on quality and care.

Qualifications

• 1–3 years of clinical research experience, preferably in regulatory or quality assurance.
• Solid understanding of regulatory requirements.
• Highly organized and adept at managing priorities.

Responsibilities

• Prepare and submit regulatory documents for studies.
• Liaise with sponsors and ethics committees.
• Maintain regulatory files and track document updates.
• Support staff with documentation requests and studies.
• Coordinate with internal teams on start-up activities.
• Manage essential document signatures and tracking.
• Ensure readiness for audits and inspections.

Skills

Clinical research experience

Understanding of ICH/GCP and FDA regulations

Organizational skills

Clear communication

Attention to detail

Proactive problem solving

Experience with document management systems

Tools

CTMS

EDC

Job description

A leading clinical research network is hiring a Regulatory Specialist in Toronto, Ontario. This full-time role involves preparing and submitting regulatory documents essential for clinical trials, ensuring compliance with regulations. Candidates should have 1-3 years of clinical research experience, strong organizational skills, and familiarity with ICH/GCP and FDA requirements. The role offers an opportunity to contribute to efficient trial processes and facilitate collaboration among various stakeholders. Join a mission-driven team dedicated to advancing scientific research while maintaining a focus on quality and care.