Bilingual Clinical Research Associate (Level II) – Quebec

About the role

Join a global CRO team supporting leading pharmaceutical and biotech companies. As a Bilingual Clinical Research Associate (Level II) you will monitor investigator sites in Quebec, ensuring compliance with protocols, ICH‑GCP guidelines and local regulations while safeguarding subject safety and data integrity.

Key responsibilities

• Perform remote and on‑site monitoring visits using a risk‑based approach.
• Apply root‑cause analysis to identify site process failures and implement corrective actions.
• Conduct source data verification (SDV), source data review (SDR) and CRF review to ensure data accuracy.
• Assess investigational product inventory and documentation.
• Document findings in monitoring reports and letters, escalating issues as needed.
• Maintain regular communication with sites to resolve outstanding findings.
• Participate in investigator payment processing and investigator meetings.
• Assist in site initiation, qualification, and trial close‑out activities.

Required profile

• Bilingual in English and French.
• Experience conducting clinical monitoring for pharmaceutical or biotech studies.
• Strong knowledge of ICH‑GCP, local regulations and SOPs.
• Ability to travel within Quebec for on‑site visits.
• Excellent written communication and documentation skills.

Required skills

• ICH‑GCP compliance
• Risk‑based monitoring
• Root cause analysis
• Source data verification (SDV)
• Source data review (SDR)
• CRF review