Senior Clinical Research Associate

Senior Clinical Research Associate

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. We are looking for a CRA in Quebec City to monitor CV and respiratory studies.

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

En tant que Conseiller(ère) principal(e) en recherche clinique (Senior CRA) chez ICON Plc, vous superviserez et gérerez les activités liées aux essais cliniques afin de garantir leur réalisation conformément aux protocol es, aux exigences réglementaires et aux normes de l’industrie. Nous sommes à la recherche d’un(e) CRA basé(e) à Québec pour assurer le suivi d’études en cardiovasculaire et respiratoire.

Vous dirigerez des activités de surveillance d’essais cliniques exigeant une solide expertise technique, avec un accent particulier sur la qualité et l’amélioration continue.

• Effectuer le suivi des sites d’essais cliniques afin de s’assurer du respect des protocol es d’étude, des exigences réglementaires et des normes de Bonnes Pratiques Cliniques (BPC/GCP).
• Réaliser des visites de sites pour évaluer leur performance, résoudre les problématiques et fournir le soutien nécessaire à la réussite des essais.
• Collaborer avec des équipes multidisciplinaires afin d’assurer une collecte de données et une production de rapports exactes et réalisées dans les délais.
• Offrir de la formation et du soutien au personnel des sites ainsi qu’aux autres ARC/CRA afin de maintenir des normes élevées de conduite des essais cliniques.
• Établir et entretenir des relations de travail efficaces avec le personnel des sites et les principales parties…