Job detail

Sr CRA

ICON plc

#Oncology #Regulatory Requirements #CRA #Site Monitoring #Clinical Research Associate #Healthcare Intelligence #ICH-GCP #Medical Data #Clinical Trial Operations

Quick overview

Coordinate the setup and monitoring of oncology clinical trials while maintaining accurate study documentation and reports. Build collaborative relationships with investigators and site staff to ensure patient safety and regulatory compliance.

Requirements summary

Requires a university degree in medicine or science and proven experience monitoring oncology studies. Must have strong knowledge of ICH-GCP guidelines and the ability to travel approximately 60% of the time.

bachelor degreeStakeholder ManagementRegulatory CompliancePatient SafetyFeasibility StudiesEnglish CommunicationClinical Trial MonitoringOncology MonitoringStudy DocumentationICH-GCP GuidelinesMedical Data Evaluation

Job description

Clinical Research Associate ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a CRA at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programs.
This is a sponsor dedicated program focused on monitoring Oncology studies in Montreal.
What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders.
Key responsibilities include: Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff.
Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements.
Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.
Required qualifications and experience: University degree in medicine, science, or equivalent Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data Excellent written and verbal communication in English Experience monitoring Oncology studies Good social skills enabling you to deal with queries in a timely manner Willingness to travel as required (approximately 60%) En tant que CRA chez ICON, vous contribuerez à la fonction des opérations d’essais cliniques en travaillant de manière collaborative afin de fournir des résultats de haute qualité dans le cadre de nos programmes cliniques.
Il s’agit d’un programme dédié sponsorisé, axé sur le suivi d’études en oncologie dans l’Ouest canadien.
Vos responsabilités : Votre rôle consistera à assurer le suivi des essais cliniques selon des standards élevés, en collaboration étroite avec votre équipe et les parties prenantes.
Principales responsabilités : Travailler de manière autonome et proactive pour coordonner toutes les activités liées à la mise en place et au suivi des études, rédiger des rapports d’avancement précis et maintenir la documentation des études.
Gérer efficacement les demandes (queries) émises par le sponsor et être responsable de l’optimisation des coûts des études ; participer également à la préparation et à la revue de la documentation des études ainsi qu’aux études de faisabilité pour de nouvelles propositions, si nécessaire.
Développer et maintenir des relations solides et collaboratives avec les parties prenantes clés, les investigateurs cliniques et le personnel des sites.
Garantir la sécurité des patients en assurant la conformité avec les procédures d’ICON, les protocoles et les exigences réglementaires.
Votre profil : Vous apporterez une expérience pertinente en monitoring d’essais cliniques, ainsi que les qualifications et compétences suivantes : Qualifications et expérience requises : Diplôme universitaire en médecine, sciences ou équivalent Connaissance des directives ICH-GCP et capacité à examiner et évaluer des données médicales Excellentes compétences en communication écrite et orale en anglais Expérience en monitoring d’études en oncologie Bonnes compétences relationnelles permettant de traiter les demandes (queries) de manière efficace et en temps opportun Disponibilité pour des déplacements professionnels fréquents (environ 60 %) Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility ICON is an equal opportunity employer.
We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee?
Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
If you’re as driven as we are, join us.
You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
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Sr CRA

Quick overview

Requirements summary

Job description

Benefits

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