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

Job Title: Unblinded Monitor (Casual Hours, Bilingual - French/English)

Project: Controlled Human Infection Model (CHIM) Study

Location: Montreal/hybrid-remote

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

Position Summary

The Unblinded Monitor will support the conduct of a Controlled Human Infection Model (CHIM) and other Phase 1 studies by overseeing study elements that require access to unblinded information, including treatment allocation and investigational product handling. This role is critical to ensuring participant safety and protocol compliance while maintaining strict separation from blinded study personnel and activities. (Casual)

Key Responsibilities

• Access and manage unblinded study information, including treatment allocation and investigational product details
• Ensure proper handling, storage, accountability, and documentation of investigational products
• Monitor protocol compliance for unblinded procedures and activities
• Support safety oversight, including review and escalation of adverse events as required
• Maintain strict separation between blinded and unblinded study functions to preserve study integrity
• Collaborate with pharmacy, laboratory, and clinical teams involved in unblinded processes
• Document and report protocol deviations related to unblinded aspects of the study
• Participate in monitoring activities (on-site or remote) as needed
• Support audit readiness and regulatory inspections related to unblinded processes

Qualifications

• Bachelor's degree in health sciences, life sciences, nursing, pharmacy, or a related field
• Experience in clinical research, clinical trial monitoring, or investigational product management (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 ability to manage sensitive/unblinded information
• Excellent organizational and documentation skills
• Strong communication and problem-solving abilities
• Ability to work independently with a high level of accountability
• Familiarity with investigational product handling and documentation requirements
• Proficiency with electronic data capture systems and Microsoft Office

Working Conditions

• Casual, as-needed hours based on study activities and enrollment timelines
• On-site presence may be required for investigational product oversight or key study procedures
• Must be able to work in a clinical research environment with adherence to biosafety protocols

Additional Notes

• This role requires strict adherence to procedures that prevent unblinded information from being shared with blinded study personnel
• Training specific to CHIM protocols, investigational product handling, and biosafety requirements will be provided