500402 Clinical Associate

CTA, Homebased, Canada

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re 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.

We are currently seeking a Clinical Associate to join our diverse and dynamic team. As a Clinical Associate at ICON, you will play a pivotal role in supporting the design, implementation, and management of clinical trials, contributing to the advancement of innovative treatments and therapies.

What you will be doing

• Services/deliverables include the management of all documents and logistical and administrative tasks related to trial feasibility, start-up, execution and close out of clinical trials. 
• Ensures trial related activities are compliant with GCO SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements. Further services/deliverables will include technical regulatory document review, including Informed Consent Forms. Partners with the Local Trial Manager (LTM) and Site Manager (SM) to ensure overall site management while performing trial related activities for assigned protocols.
• Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.
• Complies with relevant training requirements.
• Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM and SM.
• Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.
• Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.
• Collects and files all documents throughout the trial and post-trial. Uses appropriate systems to ensure file completeness at designated study milestones. Coordinates archiving of paper study relevant documents/files.
• Ensures audit and inspection readiness.
• Provide process improvement suggestions if applicable.
• Negotiates site requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.
• Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA, in support of the LTM/TM/SM where applicable.
• Collects and tracks financial disclosure information at appropriate timepoints in accordance with procedural documents.
• Prepares study files for investigational sites and co-ordinates the development of associated documents and review them for completeness and accuracy.
• Provides updates to study specific internal data repositories to ensure availability of trial documents to the study team.
• If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
• If requested, organizes training for SM(s) and/or SIV/small investigator meetings.
• If applicable, region-specific deliverables will be specified.
• Les services et livrables incluent la gestion de l’ensemble des documents ainsi que des tâches logistiques et administratives liées à l’étude de faisabilité, au démarrage, à l’exécution et à la clôture des essais cliniques.
• Assure que les activités liées à l’essai sont conformes aux SOP de GCO, aux politiques, aux Bonnes Pratiques Cliniques (BPC/GCP), aux exigences de conformité en matière de santé (HCC) ainsi qu’aux exigences réglementaires locales. Les services et livrables comprennent également l’examen technique des documents réglementaires, y compris des formulaires de consentement éclairé. Collabore avec le Local Trial Manager (LTM) et le Site Manager (SM) afin de garantir la gestion globale du site tout en exécutant les activités liées à l’essai pour les protocoles assignés.
• Les services fournis respecteront les SOP, WI, politiques du client, ainsi que les exigences réglementaires locales applicables.
• Respecte les obligations de formation requises.
• Fournit les livrables suivants : suivi de l’avancement de l’essai clinique, gestion des données de l’étude, du budget, des produits expérimentaux, des envois et correspondances, ainsi que d’autres tâches pertinentes en soutien au LTM/TM et au SM.
• Maintient les informations relatives au protocole au niveau de l’essai, du pays et du site dans les systèmes de gestion d’essais, y compris, mais sans s’y limiter, les systèmes nécessaires pour assurer la distribution appropriée des mises à jour de sécurité.
• Veille à ce que les versions actuelles des documents requis pour l’essai, ainsi que le matériel et les fournitures associés, soient fournis aux sites investigateurs dans les délais requis.
• Collecte et archive tous les documents tout au long de l’essai et après sa clôture. Utilise les systèmes appropriés pour garantir l’exhaustivité des dossiers aux étapes désignées de l’étude. Coordonne l’archivage des documents/dossiers papier liés à l’étude.
• Assure la préparation aux audits et inspections.
• Propose des améliorations de processus, le cas échéant.
• Négocie les modifications demandées par les sites concernant les accords de confidentialité ; vérifie les investigateurs et les comités d’éthique (IEC/IRB) dans les bases d’exclusion, les enregistrements et alertes IEC/IRB, le cas échéant ; et effectue d’autres tâches pertinentes en soutien à la faisabilité de l’étude et à l’évaluation des sites.
• Collecte/prépare les documents requis pour l’étude, tels que ceux nécessaires au démarrage/soumission aux IEC/IRB et aux autorités sanitaires, en soutien au LTM/TM/SM, lorsque applicable.
• Collecte et suit les informations de divulgation financière aux moments requis conformément aux documents procéduraux.
• Prépare les dossiers de l’étude pour les sites investigateurs, coordonne le développement des documents associés et vérifie leur exhaustivité et leur exactitude.
• Fournit des mises à jour aux référentiels internes spécifiques à l’étude afin d’assurer la disponibilité des documents de l’essai pour l’équipe de l’étude.
• Si demandé, gère le budget de l’étude, y compris les dépenses de l’affilié, la gestion des fournisseurs (y compris le rapprochement des factures et le budget final), en coordination avec le service des comptes fournisseurs si nécessaire.
• Si demandé, organise des formations pour les SM et/ou des réunions d’investigateurs (SIV ou réunions réduites).
• Le cas échéant, des livrables spécifiques à la région seront précisés.

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Your profile

• Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field.
• Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry.
• Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively.
• Excellent attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance.
• Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships with study teams and clinical sites.
• Licence ou diplôme avancé en sciences de la vie, sciences de la santé ou dans un domaine connexe.

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 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 family’s 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. 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 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 – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply