Jun 22, 2022

Job Description

46,000! That is the number of patients in clinical trials globally at Novartis. The Trial Monitoring organization (TMO) drives execution of clinical trials in countries ensuring highest quality monitoring at sites As a Clinical Research Associate, you will participate to the Canadian implementation and the conduct of clinical trials at different sites on investigational therapies that have the potential to significantly improve patient outcomes.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trials. Recommends sites to participate in clinical trial
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan, ICH/GCP 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.
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Attends onboarding, disease indication and project specific trainings and general CRA trainings as required
• Participates to audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Up to 2 years pharmaceutical industry experience with monitoring experience.
• Excellent communication skills (oral and written), ability to influence others.
• Ability to manage sites independently; Proven ability to work independently with minimal supervision.
• Good strategic thinking.
• Ability to anticipate potential issues and take appropriate actions with or without supervision.
• Advanced data accuracy: Ability to work focused with a great attention to detail.

You’ll receive:
An inspired, engaging and dynamic team of individuals to work with. Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme. Find out more about Novartis Canada: https://www.novartis.ca/

Why consider Novartis?
766 million. That’s how many lives our products touched in 2021. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Global Drug Development
Research & Development
Full Time
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Clinical Research Associate - Alberta and British-Columbia

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