Clinical Research Associate

Job Description Summary

Location: Montreal, #LI-Remote

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the role:

We are seeking a Clinical Research Associate with a risk-based and open mindset willing to build and maintain successful site relationships ensuring sustainable trial execution through site management at our research sites.

This role will work directly with the SSO Canada team and reports to the CRA Manager.

Job Description

Key responsibilities:

• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate.
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results.
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.

What you’ll bring to the role:

Essential:

• Decision capability
• Excellent time management and organization capabilities, including ability to prioritize and multi-task
• Risk based mindset (from issue management to risk identification) supported by Novartis systems
• Early adopter and open mindset across borders to support one study approach
• Good knowledge of drug development process specifically clinical trial/research
• Clinical and therapeutic knowledge
• Knowledge of international standards (GCP/ICH, FDA, EMA)
• Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI Oversight; GCP/ICH & Protocol Compliance)
• Fluent in both written and spoken French and English

Desirable:

• Clinical and therapeutic knowledge should include Oncology

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences

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