Clinical Research Associate - Quebec

Pharmaceutical Research Associates, Inc; Quebec; On-site; CAD 70,000 - 90,000; Full time

Job summary

A clinical research organization is seeking a Clinical Research Associate to conduct site visits, manage relationships, and ensure compliance with study protocols. Candidates should have a degree in sciences or nursing, knowledge of ICH-GCP, and monitoring experience. This role offers opportunities for travel and professional development in a dynamic environment.

Qualifications

• Trained CRA with on-site monitoring experience.
• Willing and able to travel up to 60% or as required.
• Possession of a full driver's license.

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.
• Proactive site management including building and maintaining professional relationships.

Skills

Monitoring experience

Knowledge of ICH-GCP

Fluent in English

Computer skills

Education

BA/BS/BSc in sciences or nursing

Tools

Trial management databases

Common software packages

Job description

Overview

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

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 with recruitment strategies and action plans at the site level.
• Maintaining site audit/inspection readiness.
• Ensuring appropriate safety reporting and use of online safety reporting 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 as 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.
• Trained CRA with on-site monitoring experience.

• Comprehensive knowledge of ICH-GCP.
• Fluent in oral 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, remotely or off-site.
• Proficient in computer skills and familiar with common software packages.
• Knowledge of trial management databases and online systems.
• Able to attend a one-week face-to-face training course during onboarding.
• Willing to work on multiple protocols/therapy areas.
• Experience in phase II and III trials (preferred).
• Knowledge of Electronic Data Capture (preferred).

Additional preferred experience includes working in oncology, centralized/risk-based/targeted monitoring, and metric-based environments.