Senior Clinical Research Associate/Clinical Research Associate - FSP

The Clinical Research Associate (CRA) supports the delivery of clinical studies at allocated sites, ensuring compliance with international guidelines and local regulations. They collaborate with study teams, monitor site performance, and manage study documentation to facilitate successful clinical trials.

Location: Canada

Responsibilities

• Contribute to investigator selection and site start-up activities.
• Train and support investigators and site staff in study procedures and compliance.
• Monitor study sites through visits and remote checks, ensuring data quality and protocol adherence.
• Manage study supplies, drug accountability, and site documentation.
• Perform data review, source data verification, and risk assessments.
• Ensure timely reporting of adverse events and study issues.
• Prepare for audits and inspections, maintaining inspection-ready site files.
• Ensure compliance with sponsor standards, local regulations, and company policies.

Requirements

• Bachelor’s degree in life sciences or related field.
• Knowledge of ICH-GCP, GMP/GDP, and local regulations.
• Experience in clinical trial monitoring and site management.
• Excellent attention to detail and communication skills.
• Fluency in English and local language(s).
• Ability to travel nationally/internationally and hold a valid driver’s license.