Clinical Research Associate monitoring clinical trials for pharmaceutical and biotech clients. Ensuring site compliance, data accuracy, essential documentation, and audit readiness across Alberta.
About the role
- Senior Clinical Research Associate overseeing clinical trial sites for Novo Nordisk, a pharmaceutical company developing treatments for chronic diseases. Ensuring compliant monitoring, patient safety, data integrity and timely study execution.
Responsibilities
- Own the day-to-day oversight of assigned clinical trial sites
- Oversee and manage sites through on-site and remote monitoring visits
- Ensure compliance with protocols, ICH-GCP and regulatory requirements
- Apply RBQM principles to identify, assess and mitigate risks proactively
- Track site performance, recruitment, retention and data collection
- 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
- Work with cross-functional colleagues supporting clinical trial execution
Requirements
- A bachelor’s degree in Life Sciences or a related field
- 5+ years of experience as a CRA
- Strong understanding of ICH-GCP, regulatory requirements and clinical trial methodology
- Track record of delivering high-quality trial activities in line with ICH-GCP, regulatory requirements and internal SOPs
- Hands-on proficiency with clinical trial systems such as EDC, CTMS and eTMF
- Strong organisational, time and project management skills
- Ability to manage multiple sites and priorities with high attention to detail
- Sound problem-solving and decision-making skills
- Ability to spot and mitigate risks proactively
- Excellent written and verbal communication
- Ability to build strong relationships with internal and external stakeholders at all levels
- Ability to work independently and as part of a team in a dynamic environment
- Integrity and clear focus on quality and patient safety
- Openness to new technologies and digital tools
- Ability to travel up to 70% of the time
- Practical experience applying Risk-Based Quality Management (RBQM) principles in study conduct is useful, but not essential
Benefits
- Short-term (STI) and/or long-term (LTI) incentives may be included in the salary package
- Continuous learning
- Career development
- Benefits tailored to your life and career stage
- Relevant learning offerings
- Support to perform at your best
- Continuous improvement opportunities
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