Global Clinical Trial Associate - Home-Based (US or 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.

Position Summary:

The Clinical Trial Associate is responsible for providing support to Clinical Trial Managers and cross-functional Study Teams for the execution of clinical trials.

Résumé du poste

L’associé(e) aux essais cliniques est chargé(e) de fournir un soutien aux gestionnaires d’essais cliniques et aux équipes d’étude interfonctionnelles pour l’exécution des essais cliniques.

• Organizes Study Team meetings and prepares meeting minutes
• Assists with organizing Investigator Meetings
• Assists with preparation and review of study documents
• Ships study documents and supplies to investigational sites and tracks delivery
• Assists with site management activities, including enrollment tracking, entries into Clinical Trial Management System and communication with investigational sites and Clinical Research Associates
• Submits study documentation to Trial Master File
• Contributes to department initiatives and process improvement efforts
• May assist with oversight of vendors, including review of vendor documents and invoices

Responsabilités :

• Organiser les réunions de l’équipe d’étude et préparer les procès-verbaux des réunions
• Aider à l’organisation des réunions des chercheurs
• Aider à la préparation et à la vérification des documents d’étude
• Expédier les documents d’étude et les fournitures aux centres expérimentaux et assurer le suivi de la livraison
• Aider aux activités de gestion du centre, y compris le suivi des inscriptions, les entrées dans le système de gestion des essais cliniques et la communication avec les centres de recherche et les associés de recherche clinique
• Soumettre la documentation de l’étude au fichier maître de l’essai
• Contribuer aux initiatives du service et aux efforts d’amélioration des processus
• Aider éventuellement à la surveillance des fournisseurs, y compris l’examen des documents et des factures des fournisseurs

• Bachelor's degree in life sciences discipline or relevant discipline preferred
• Typically requires 2 year of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
• Basic working knowledge of GCP, CFR and ICH guidelines and clinical trial operations
• Ability to work well with cross-functional Study Team and investigational sites
• Written, verbal and interpersonal skills to exchange straightforward information
• Demonstrates attention to detail
• Ability to work successfully under pressure with tight timelines
• Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
• Demonstrates ability to identify issues and resolve them with guidance as needed

Compétences :

• Diplôme de baccalauréat dans une discipline des sciences de la vie ou une discipline pertinente
• Généralement 2 ans d’expérience de travail pertinente dans l’industrie biopharmaceutique ou une combinaison équivalente d’études et d’expérience sont requis.
• Connaissance pratique de base des directives BPC, CFR et CIH et des opérations d’essais cliniques
• Capacité à bien travailler avec l’équipe d’étude interfonctionnelle et les centres de recherche
• Compétences en communication écrite, verbale et interpersonnelle pour échanger des informations simples
• Démontrer une attention aux détails
• Capacité à travailler avec succès sous pression avec des délais serrés
• Maîtrise des applications Microsoft Office, notamment Outlook, Excel, Word et PowerPoint
• Démontrer une capacité à identifier les problèmes et à les résoudre avec des conseils au besoin

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/benefitsAt 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-accommodationsInterested 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.

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**