Study Start-Up Coordinator

📋 Description

• Serve as the primary point of contact for clinical research sites throughout the study start-up
• Prepare, review, and submit clinical trial applications and regulatory documentation to Health
• Ensure that all regulatory submissions comply with applicable Canadian regulations, guidelines, and
• Advise internal study teams on evolving regulatory requirements, submission procedures, and
• Coordinate, track, and ensure the timely collection and filing of essential study start-up
• Monitor submission progress and follow up with relevant stakeholders to support efficient study

🎯 Requirements

• Bachelor's degree in a scientific, life sciences, or health-related discipline.
• 3 to 5 years of professional experience in the clinical research industry, with hands-on experience
• Previous experience working within a Contract Research Organization (CRO) is strongly preferred.
• Strong knowledge of Health Canada regulatory submission requirements, ICH-GCP guidelines, and
• Experience preparing, reviewing, coordinating, and tracking regulatory documentation for clinical
• Excellent written and verbal communication skills, with the ability to interact effectively with

🎁 Benefits

• Competitive compensation: Attractive compensation programs that recognize and reward individual
• Comprehensive healthcare: Access to health and wellness benefits designed to support employees'
• Retirement benefits: Retirement savings and benefits programs.
• Paid time off: Generous paid time off (PTO) to support work-life balance.
• Professional development: Structured onboarding and industry-recognized training programs to help
• Continuous learning: Ongoing training opportunities and access to experienced mentors and clinical