Job Title

Sr. CRA, Alberta/Calgary, Oncology ICON plc is a world-leading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Senior CRA you will be joining the worlds largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant quARC (Associ(e) de recherche clinique), vous rejoindrez la plus grande et la plus complte organisation de recherche clinique au monde, propulse par lintelligence en sant. What You Will Be Doing: Contribute to the identification of new sites for clinical trials Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators. Facilitate 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 appropriate. 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 continuous 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 completion performance of assigned global and local training. Responsabilits: Contribuer lidentification de nouveaux centres pour des tudes cliniques Assumer un rle dambassadeur pour faciliter les communications entre les centres dtude et le Directeur de lexprience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs. Faciliter la prparation et la collecte des documents aux centres dtude et lchelle du pays pendant toutes les phases dtude. Soutenir le travail du gestionnaire de ltude clinique pour la surveillance des fichiers matres de ltude (FME) aux centres dtude et lchelle du pays. Pendant toutes les phases dtude, sassurer que larchivage est conforme aux procdures dexploitation normalises. Effectuer linitiation des centres dtude et la formation du personnel, rdiger le rapport de la visite dinitiation. Mettre en place la structure complte de gestion des centres dtude, entre autres, les visites de surveillance, les valuations rglementaires, la gestion de lapprovisionnement en mdicaments, pour assurer la conformit au protocole, aux BPC, aux rglementations mondiales et locales, et aux processus mondiaux et locaux. Identifier les problmes aux centres dtude; rsoudre les problmes et les communiquer un palier suprieur de la direction, le cas chant. Effectuer la rdaction complte et la distribution des rapports sur les visites de surveillance, conformment aux procdures dexploitation normalises pertinentes. Examiner et grer continuellement les donnes recueillies aux centres dtude, afin de rsoudre rapidement les problmes techniques et de contenu pour atteindre les cibles de verrouillage de la base de donnes en temps opportun. Mettre en uvre les activits de clture des centres dtude et rdiger le rapport de clture des centres dtude. Fournir des commentaires sur les performances des centres dtude afin dvaluer leur candidature pour de futures tudes cliniques. Your Profile: Bachelors Degree or higher in life sciences or equivalent Minimum 3 years clinical site monitoring experience from CRO or Pharmaceutical company Comprehensive knowledge and understanding of ICH-GCP Able and willing to travel up to 60% regionally Able and willing to work on several protocols/therapy areas Experience in phase I-IV trials Working knowledge of Electronic Data Capture (preferred) Experience/working knowledge of the oncology disease area Experience of Centralized/Risk Based/Targeted monitoring (preferred) Experience of working within a metric based environment (preferred) Excellent attention to detail Highly developed time management and organizational skills Focused on meeting study deliverables/targets Flexible and willing to adapt to changing priorities/timelines Experience in oncology is required Comptences Baccalaurat ou diplme suprieur en sciences de la vie ou un quivalent Minimum de 3 4ans dexprience en surveillance de centres dtude pour une entreprise de recherche contractuelle ou une socit pharmaceutique Des connaissances et une comprhension approfondies des bonnes pratiques cliniques labores par la Confrence internationale sur lharmonisation (BPC-CIH) Bilinguisme franais/anglais (matrise verbale et crite) exig Dispos(e) et apte voyager jusqu 60% du temps lchelle rgionale Dispos(e) et apte travailler sur plusieurs protocoles/domaines thrapeutiques Exprience dans les tudes cliniques de phaseI IV Connaissance pratique de la saisie lectronique des donnes (prfrable) Exprience/connaissance pratique dans le domaine des maladies oncologiques Exprience dans la surveillance centralise/axe sur les risques/cible (prfrable) Exprience de travail dans un environnement mtrique (prfrable) Souci du dtail Comptences organisationnelles et de gestion du temps de haut niveau Dtermin(e) fournir les livrables et atteindre les objectifs des tudes Flexible et dispos(e) sadapter aux changements dans les priorits/chanciers What ICON can offer you: Our success depends on the quality of our people. Thats why weve 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 familys needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your familys well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. Were 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 or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply #J-18808-Ljbffr