As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations.
- Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Manages reporting of protocol deviations and appropriate follow-up.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Manages reporting of identified issues and manages follow-up to resolution.
- Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan.
- Ensures all activities are managed by site personnel who are appropriately delegated and trained.
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks.
- Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.)
- Conduct Follow-up for Escalated AEM Report Query
- Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
- Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log).
- Will collaborate with primary Site Manager who will act as the primary liaison with site personnel.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
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’étude; résoudre les problèmes et les communiquer à un palier supérieur de la direction, le cas échéant.
- Effectuer la rédaction complète et la distribution des rapports sur les visites de surveillance, conformément aux procédures d’exploitation normalisées pertinentes.
- Examiner et gérer continuellement les données recueillies aux centres d’étude, afin de résoudre rapidement les problèmes techniques et de contenu pour atteindre les cibles de verrouillage de la base de données en temps opportun.
- Mettre en œuvre les activités de clôture des centres d’étude et rédiger le rapport de clôture des centres d’étude.
- Fournir des commentaires sur les performances des centres d’étude afin d’évaluer leur candidature pour de futures études cliniques.
- Améliorer ses compétences en complétant en temps opportun les cours de formation mondiaux et locaux désignés.
You are:
Training and Education
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Prior Experience
- 3+ years experience as a CRA/Clinical Monitor with demonstrated monitoring experience (virtual or onsite)
Technical Competencies
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Demonstrated networking and relationship building skills
- Ability to manage required travel of up to 75% on a regular basis
- Ability to communicate effectively and appropriately with internal & external stakeholders
- Ability to adapt to changing technologies and processes
- Demonstrated experience of utilising systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice
Behavioral Competencies
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Compétences
- Baccalauréat ou diplôme supérieur en sciences de la vie ou un équivalent
- Minimum de 2 à 4 ans d’expérience en surveillance de centres d’étude pour une entreprise de recherche contractuelle ou une société pharmaceutique
- Des connaissances et une compréhension approfondies des bonnes pratiques cliniques élaborées par la Conférence internationale sur l’harmonisation (BPC-CIH)
- Bilinguisme français/anglais (maîtrise verbale et écrite) exigé
- Disposé(e) et apte à voyager jusqu’à 60 % du temps à l’échelle régionale (centres d’étude à Québec et à Montréal)
- Disposé(e) et apte à travailler sur plusieurs protocoles/domaines thérapeutiques
- Expérience dans les études cliniques de phase I à IV
- Connaissance pratique de la saisie électronique des données (préférable)
- Expérience/connaissance pratique dans le domaine des maladies oncologiques (préférable, mais non requise)
- Expérience dans la surveillance centralisée/axée sur les risques/ciblée (préférable)
- Expérience de travail dans un environnement métrique (préférable)
- Compétences organisationnelles et de gestion du temps de haut niveau
- Déterminé(e) à fournir les livrables et atteindre les objectifs des études
- Flexible et disposé(e) à s’adapter aux changements dans les priorités/échéanciers
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Les avantages de travailler pour ICON:
Notre succès dépend des connaissances, des capacités et de la qualité de notre personnel. C’est pourquoi nous nous engageons à former nos employé(e)s dans une culture d’apprentissage continu — une culture où nous vous mettons au défi de faire du travail intéressant et où chaque expérience contribue à votre perfectionnement professionnel.
Chez ICON, notre objectif est de vous offrir une rémunération globale complète et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large éventail de programmes de rémunération variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-être de première qualité, afin de vous soutenir, vous et votre famille, à toutes les étapes de votre carrière, maintenant et à l’avenir.
ICON, y compris ses filiales, est un employeur inclusif qui offre des chances égales et s’engage à offrir un cadre de travail exempt de discrimination et de harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d’une considération égale pour l’emploi, sans distinction par rapport à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap ou le statut d’ancien combattant protégé.
Si, en raison d’un problème de santé ou d’un handicap, vous avez besoin d’aménagements adaptés et raisonnables pour toute partie du processus de candidature, ou pour exécuter les fonctions essentielles d’un poste, veuillez nous en informer au moyen du formulaire ci-dessous.
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