Clinical Research Associate- Quebec

Pharmaceutical Research Associates, Inc; Quebec; On-site; CAD 60,000 - 85,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Research Associate (CRA) to conduct clinical trial site visits and ensure operational excellence. The successful candidate will foster relationships with site staff, facilitate subject enrollment, and promote compliance with trial protocols. This role requires a degree in life sciences or nursing and offers opportunities for travel and professional development.

Qualifications

• Trained CRA with on-site monitoring experience.
• Comprehensive knowledge of ICH-GCP and local regulations.
• 1-2 years of on-site clinical monitoring experience preferred.

Responsibilities

• Conduct clinical trial site visits including evaluation, initiation, monitoring, and close-out.
• Oversee and report on the conduct of clinical trials at a site level.
• Maintain site audit/inspection readiness.

Skills

Knowledge of ICH-GCP

Fluency in English

Proficiency with software

Education

BA/BS/BSc in sciences or nursing

Tools

Electronic Data Capture systems

Job description

Overview

As a CRA, you will join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

En tant qu’ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en santé.

Responsibilities

What you will be doing:

• Conduct clinical trial site visits including evaluation, initiation, monitoring, and close-out.
• Oversee and report on the conduct of clinical trials at a site level, including online site visit reports and updates to electronic management systems.

• Proactive site management including:

• Building and maintaining solid and professional relationships with site staff.
• Facilitating subject enrollment by incorporating recruitment strategies and action plans at the site level.
• Maintaining site audit/inspection readiness.
• Ensuring appropriate safety reporting and use of online safety reporting/review systems such as Intralinks.
• Verifying electronic case report form data against source documentation as per study schema/monitoring plan.
• Responding to site queries and escalating issues per processes and timelines.
• Conducting IP accountability and reconciliation.
• Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting).
• Maintaining site study supplies.

Operational Excellence:

• Contribute to sponsor goals.
• Promote operational and scientific excellence.
• Identify opportunities and best practices with local/regional partners to enhance operational effectiveness.

Gestion des sites d’essais cliniques

• Effectuer des visites de sites d’essais cliniques : incluant l’évaluation, l’initiation, la surveillance et la clôture.
• Superviser et rendre compte de la conduite des essais cliniques : au niveau du site, y compris les rapports de visites en ligne et les mises à jour des systèmes de gestion électroniques.
• Gestion proactive des sites, incluant :

• Établir et maintenir des relations solides et professionnelles avec le personnel du site.
• Faciliter l’enrôlement des sujets en intégrant des stratégies de recrutement et des plans d’action au niveau du site.
• Maintenir la préparation à l’audit/inspection du site.
• Assurer la déclaration appropriée des événements indésirables et l’utilisation des systèmes de déclaration/évaluation en ligne tels qu’Intralinks.
• Vérifier les données des formulaires électroniques de rapport de cas (eCRF) par rapport à la documentation source écrite et électronique, conformément au schéma de l’étude/plan de surveillance.
• Répondre aux questions du site et escalader les problèmes conformément aux processus et délais.
• Effectuer la responsabilité et la réconciliation des produits de l’essai (IP).
• Faciliter la mise en œuvre de nouvelles technologies et systèmes sur les sites cliniques (Collecte de données électronique, déclaration eSAE).
• Maintenir les fournitures d’étude du site.

Excellence opérationnelle

• Contribuer aux objectifs du promoteur.
• Promouvoir l’excellence opérationnelle et scientifique.
• Identifier les opportunités et les meilleures pratiques avec les partenaires locaux/régionaux qui contribueront à l’efficacité opérationnelle globale.

Qualifications

You are:

• BA/BS/BSc in sciences or nursing, or equivalent.
• A trained CRA with on-site monitoring experience.

• Comprehensive knowledge of ICH-GCP.
• Fluent in spoken and written English.
• Willing and able to travel up to 60% or as required.
• Possession of a full driver’s license.
• Willing to work from a designated home office as per local requirements.
• Willing to attend team meetings and mandatory training (remote or off-site).
• Proficient with common software and trial management systems.
• Knowledge of Electronic Data Capture systems (preferred).
• Experience in phase II and III trials (preferred).
• Experience in oncology (preferred).
• Experience with centralized, risk-based, or targeted monitoring (preferred).

Additional qualifications include a university degree in life sciences or nursing (equivalent of BA/BS/BSc), certification as a registered nurse or similar, 1-2 years of on-site clinical monitoring experience, and knowledge of GCP and local regulations.