Job Description

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 taches logistiques et administratives liees a l'etude de faisabilite, au demarrage, a l'execution et a la cloture des essais cliniques.
• Assure que les activites liees a l'essai sont conformes aux SOP de GCO, aux politiques, aux Bonnes Pratiques Cliniques (BPC/GCP), aux exigences de conformite en matiere de sante (HCC) ainsi qu'aux exigences reglementaires locales. Les services et livrables comprennent egalement l'examen technique des documents reglementaires, y compris des formulaires de consentement eclaire. Collabore avec le Local Trial Manager (LTM) et le Site Manager (SM) afin de garantir la gestion globale du site tout en executant les activites liees a l'essai pour les protocoles assignes.
• Les services fournis respecteront les SOP, WI, politiques du client, ainsi que les exigences reglementaires locales applicables.
• Respecte les obligations de formation requises.
• Fournit les livrables suivants : suivi de l'avancement de l'essai clinique, gestion des donnees de l'etude, du budget, des produits experimentaux, des envois et correspondances, ainsi que d'autres taches 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 systemes de gestion d'essais, y compris, mais sans s'y limiter, les systemes necessaires pour assurer la distribution appropriee des mises a jour de securite.
• Veille a ce que les versions actuelles des documents requis pour l'essai, ainsi que le materiel et les fournitures associes, soient fournis aux sites investigateurs dans les delais requis.
• Collecte et archive tous les documents tout au long de l'essai et apres sa cloture. Utilise les systemes appropries pour garantir l'exhaustivite des dossiers aux etapes designees de l'etude. Coordonne l'archivage des documents/dossiers papier lies a l'etude.
• Assure la preparation aux audits et inspections.
• Propose des ameliorations de processus, le cas echeant.
• Negocie les modifications demandees par les sites concernant les accords de confidentialite ; verifie les investigateurs et les comites d'ethique (IEC/IRB) dans les bases d'exclusion, les enregistrements et alertes IEC/IRB, le cas echeant ; et effectue d'autres taches pertinentes en soutien a la faisabilite de l'etude et a l'evaluation des sites.
• Collecte/prepare les documents requis pour l'etude, tels que ceux necessaires au demarrage/soumission aux IEC/IRB et aux autorites sanitaires, en soutien au LTM/TM/SM, lorsque applicable.
• Collecte et suit les informations de divulgation financiere aux moments requis conformement aux documents proceduraux.
• Prepare les dossiers de l'etude pour les sites investigateurs, coordonne le developpement des documents associes et verifie leur exhaustivite et leur exactitude.
• Fournit des mises a jour aux referentiels internes specifiques a l'etude afin d'assurer la disponibilite des documents de l'essai pour l'equipe de l'etude.
• Si demande, gere le budget de l'etude, y compris les depenses de l'affilie, la gestion des fournisseurs (y compris le rapprochement des factures et le budget final), en coordination avec le service des comptes fournisseurs si necessaire.
• Si demande, organise des formations pour les SM et/ou des reunions d'investigateurs (SIV ou reunions reduites).
• Le cas echeant, des livrables specifiques a la region seront precises.

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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 diplome avance en sciences de la vie, sciences de la sante ou dans un domaine connexe.

• Experience prealable en recherche clinique ou dans le domaine de la sante, de preference au sein de l'industrie pharmaceutique, biotechnologique ou en CRO.
• Excellentes competences organisationnelles et de gestion du temps, avec la capacite de prioriser les taches et de gerer efficacement des priorites concurrentes.
• Grande attention aux details et solides competences en resolution de problemes, avec un engagement fort envers l'exactitude, l'integrite et la conformite des donnees.
• Competences efficaces en communication et en relations interpersonnelles, avec la capacite de collaborer de maniere transversale et d'etablir de solides relations avec les equipes d'etude et les sites cliniques.

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, 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 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 .
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 to apply

Skills Required