Overview
Bilingual Clinical Research Associate/Oncology CRC Jobs in Montréal – Quebec at ICON Strategic Solutions
Title: Bilingual Clinical Research Associate/Oncology CRC
Company: ICON Strategic Solutions
Location: Montréal – Quebec
Category: Research/Development
Position: Bilingual Clinical Research Associate (Oncology CRC welcome)
Overview:
ICON plc is a world-leading healthcare intelligence and
clinical research
organisation. From molecule to medicine, we advance
clinical research
providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve
quality of life
.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
Responsibilities:
Contribute to the identification of new sites for clinical trials
Assume ambassadorial role to facilita te
communication
between sites and sponsor CPO to increase value proposition to investigators.
Facilita te the preparation and collection of site and country level documents during all phases of the trial. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.Execute site initiation and training, generate initiation visit report.
Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
Identify problems at sites; resolve issues and escalate as appropria te.
Complete preparation and generation of visit monitoring reports as per relevant SOP.Review and manage data at site; resolve technical and content issues on a continuo us basis in order to achieve timely database lock targets.
Implement site close-out activities and generate site close-out report.
Provide feedback on site performance for future trial site feasibility/selection
Improve skills by timely complet ion performance of assigned global and local training. Responsabilités:
Contribuer à l’identification de nouveaux centres pour des études cliniques
Assumer un rôle d’ambassadeur pour faciliter les communications entre les centres d’étude et le Directeur de l’expérience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs.
Faciliter la préparation et la collecte des documents aux centres d’étude et à l’échelle du pays pendant toutes les phases d’étude. Soutenir le travail du gestionnaire de l’étude clinique pour la surveillance des fichiers maîtres de l’étude (FME) aux centres d’étude et à l’échelle du pays. Pendant toutes les phases d’étude, s’assurer que l’archivage est conforme aux procédures d’exploitation normalisées.
Effectuer l’initiation des centres d’étude et la formation du personnel, rédiger le rapport de la visite d’initiation.
Mettre en place la structure complète de gestion des centres d’étude, entre autres, les visites de surveillance, les évaluations réglementaires, la gestion de l’approvisionnement en médicaments, pour assurer la conformité au protocole, aux BPC, aux réglementations mondiales et locales, et aux processus mondiaux et locaux.
Identifier les problèmes aux centres d’…
