Bilingual (French/English) Blinded Monitor for Vaccine Clinical Trials

Job Title: Blinded Monitor (0.5 FTE, Bilingual - French/English)

Project: Controlled Human Infection Model (CHIM) Study

Location: Montreal/hybrid

Reports To: Lead Monitor, Atlantic Maritime Clinical Monitoring (AMCM)

Position Summary

The Blinded Monitor will support the conduct of a Controlled Human Infection Model (CHIM) and Phase 1 Vaccine studies by ensuring study integrity, participant safety, and protocol adherence while maintaining blinding. This role involves close collaboration with the clinical and research teams, with strict separation from unblinded study functions.

Key Responsibilities

• Monitor study conduct to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements
• Maintain strict blinding procedures and ensure no unblinded information is accessed or disclosed
• Review source documentation and study data for accuracy, completeness, and consistency
• Support verification of participant eligibility, informed consent, and protocol adherence
• Identify, document, and escalate protocol deviations and safety concerns as appropriate
• Liaise with study coordinators and investigators to resolve data queries and discrepancies
• Participate in monitoring visits (on-site or remote) and prepare monitoring reports
• Contribute to audit readiness and regulatory inspections
• Ensure proper documentation and filing in accordance with study and sponsor requirements

Qualifications

• Bachelor's degree in health sciences, life sciences, nursing, or a related field
• Experience in clinical research or clinical trial monitoring (preferred)
• Knowledge of Good Clinical Practice (GCP) and clinical trial regulations
• Experience with infectious disease studies or high-containment research settings is an asset

Skills & Competencies

• Fluency in both English and French (written and verbal) required
• Strong attention to detail and organizational skills
• Ability to maintain confidentiality and strict adherence to blinding requirements
• Excellent communication and problem-solving skills
• Ability to work independently in a part-time (0.5 FTE) capacity
• Proficiency with electronic data capture systems and Microsoft Office

Working Conditions

• Part-time position (0.5 FTE)
• Will require occasional on-site presence depending on study activities
• Must be able to work in a clinical research environment with adherence to biosafety protocols

Additional Notes

• Training specific to CHIM protocols and biosafety requirements will be provided