Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organization. Ensuring protocol, ICH - GCP, and regulatory compliance across investigative sites and remote studies.
About the role
- Clinical Research Associate monitoring Novo Nordisk clinical trials across Greater Montreal. Ensuring site compliance, patient safety, data integrity and timely study delivery.
Responsibilities
- Oversee and manage assigned clinical trial sites through on-site and remote monitoring visits
- Ensure compliance with protocols, ICH-GCP and regulatory requirements
- Apply RBQM principles to identify, assess and proactively mitigate risks
- Track site performance, recruitment, retention and data collection
- Act quickly to keep timelines and quality objectives on track
- Resolve discrepancies and manage adverse events
- Protect patient safety and data integrity
- Keep sites inspection-ready
- Train and support site staff on study protocols, operational procedures, systems and compliance requirements
- Represent Novo at site level
- Build trusted relationships with investigators and site teams
- Collaborate with cross-functional colleagues supporting clinical trial execution
- Contribute to continuous improvement and better ways of working
Requirements
- A bachelor’s degree in Life Sciences or a related field
- 3+ years of experience as a CRA in clinical trial monitoring, or in a relevant pharmaceutical industry or in a CRO
- Strong understanding of ICH-GCP, regulatory requirements and clinical trial methodology
- Track record of delivering high-quality trial activities in line with regulatory requirements and internal SOPs
- Hands-on proficiency with EDC, CTMS and eTMF
- Strong organisational, time and project management skills
- Ability to manage multiple sites and priorities with high attention to detail
- Problem-solving and decision-making skills, including risk identification and mitigation
- Excellent written and verbal communication skills
- Ability to build relationships with internal and external stakeholders
- Ability to work independently and as part of a team in a dynamic environment
- Integrity and focus on quality and patient safety
- Openness to new technologies and digital tools
- Ability to travel up to 70% of the time
Benefits
- Short-term (STI) and/or long-term (LTI) incentives may be included
- Continuous learning
- Career development
- Benefits tailored to your life and career stage
- Relevant learning offerings and training
- New technologies and digital tools development opportunities
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