Clinical Research Associate II — Site Monitoring Lead

AbbVie Inc.; Toronto; Presencial; CAD 81.000 - 131.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Employee stock purchase

Wellness spending account

Flexible health insurance

Retirement savings programs

Descripción de la vacante

AbbVie Inc. seeks a Clinical Site Monitoring professional to enable its world-class R&D organization and to proactively address study-related site issues across start-up, execution, and close-out of trials.

You will monitor sites to ensure protocol adherence, GCP/ICH compliance, and safety data quality, while training personnel and coordinating investigator payments. Travel up to 50% is required.

Formación

• Minimum of 2 years of clinically-related monitoring experience.
• Experience in on-site monitoring of investigational drug or device trials.
• Knowledge of ICH/GCP guidelines and applicable regulations.
• Strong planning and organizational skills.
• Ability to travel up to 50%.
• Valid driver's license and passport.
• Proficient with MS Office.
• Excellent communication and interpersonal skills.

Responsabilidades

• Monitors clinical sites to ensure protocol execution and regulatory compliance.
• Conducts site qualification, initiation, interim monitoring and closeout visits.
• Coordinates with sites and stakeholders to implement corrective actions.
• Ensures data quality and timely safety reporting from study sites.
• Maintains regulatory inspection readiness at assigned sites.
• Trains site personnel on protocol and regulatory requirements.
• Identifies and evaluates potential investigators/sites to support studies.

Educación

Appropriate tertiary qualification (health-related)

Herramientas

Microsoft Office Suite

Descripción del empleo

AbbVie Inc. seeks a Clinical Site Monitoring professional to enable its world-class R&D organization and to proactively address study-related site issues across start-up, execution, and close-out of trials.

You will monitor sites to ensure protocol adherence, GCP/ICH compliance, and safety data quality, while training personnel and coordinating investigator payments. Travel up to 50% is required.