Clinical Associate, French-Speaking
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
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
Role Summary
To be an integral part of the study team whilst acquiring clinical and corporate knowledge of clinical trial conduct. Provide administrative support to the Project Manager(s), Clinical Trial Manager(s), and/or sites, with emphasis on driving global inspection readiness.
The RoleTo be an integral part of the study team whilst acquiring clinical and corporate knowledge of clinical trial conduct.
Provide administrative support to the Project Manager(s), Clinical Trial Manager(s) and/or sites, with emphasis on driving global inspection readiness.
Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
This is a developmental role which requires extensive training. An ability and willingness to travel (drive and fly) as needed for this role and at least 60% of the time for future roles is required.
To acquire knowledge of ICH GCP, the conduct of clinical trials and governing regulations, relevant ICON SOPs, ICON internal tracking systems and client SOPs / client systems (when applicable).
To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival.
To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times.
To facilitate and coordinate ordering/dispatching and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate.
To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate).
To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly.
To assist in coordination of site/study-related payments, if applicable.
To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
To assist in the tracking and distribution of safety reports.
To coordinate document translation, if required.
To assist with, and attend, the Project team meetings, and corresponding activities preparation, generation of meeting minutes and agendas.
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
To assist with the coordination of various status and tracking reports including but not limited to team member tracking and training.
To work in collaboration with internal and external colleagues to meet project objectives and timelines.
To keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention.
To maintain client and patient confidentiality.
Other duties as assigned.
Bachelor's degree or local equivalent in life sciences or related discipline.
#LI-ZH1
Chez ICON, ce sont nos collaborateurs qui font la difference. Nos equipes diverses nous permettent de devenir un meilleur partenaire pour nos clients et de remplir notre mission : faire progresser et ameliorer la vie des patients.
Notre culture Own It repose sur quatre valeurs cles qui nous rassemblent en tant qu'individus et nous distinguent en tant qu'organisation : Responsabilite & Resultats, Collaboration, Partenariat et Integrite. Nous voulons etre l'Organisation de Recherche Clinique qui offre l'excellence a nos clients et aux patients a chaque etape. En bref, etre le partenaire de choix dans le developpement des medicaments.
C'est notre vision. Elle nous anime. Et nous avons besoin de personnes talentueuses qui la partagent.
Si vous etes aussi motive que nous, rejoignez-nous. Vous travaillerez dans un environnement dynamique et bienveillant, aux cotes de certaines des personnes les plus brillantes et les plus sympathiques du secteur, et vous contribuerez a faconner une industrie.
Resume du role
Faire partie integrante de l'equipe d'etude tout en acquerant des connaissances cliniques et organisationnelles sur la conduite des essais cliniques. Fournir un soutien administratif aux Chef(s) de Projet, Responsable(s) d'Essais Cliniques et/ou aux sites, avec un accent particulier sur la preparation mondiale aux inspections.
Le roleFaire partie integrante de l'equipe d'etude tout en acquerant des connaissances cliniques et organisationnelles sur la conduite des essais cliniques.
Fournir un soutien administratif aux Chef(s) de Projet, Responsable(s) d'Essais Cliniques et/ou aux sites, avec un accent sur la preparation mondiale aux inspections.
Reconnaitre, illustrer et respecter les valeurs d'ICON, centrees sur la responsabilite, l'integrite, le partenariat, la collaboration et l'excellence dans la prestation.
En tant que membre du personnel, l'employe est attendu a contribuer a notre culture d'amelioration des processus, visant a les rationaliser, a ajouter de la valeur a notre activite et a repondre aux besoins des clients.
Il s'agit d'un poste de developpement necessitant une formation approfondie. Une aptitude et une volonte de voyager (en voiture et en avion) selon les besoins pour ce poste, et au moins 60 % du temps pour les postes futurs, sont requises.
Acquerir des connaissances sur les ICH GCP, la conduite des essais cliniques et les reglementations en vigueur, les SOPs ICON, les systemes de suivi internes ICON et les SOPs/systemes clients (le cas echeant).*
Aider les equipes projet a la mise en place, a l'organisation et a la maintenance de la documentation des etudes cliniques (par ex. dossiers d'etude, CRF, etc.) et des lignes directrices, y compris la preparation aux audits internes/externes, la reconciliation finale et l'archivage.*
Aider au traitement des formulaires de collecte de donnees, c'est-a-dire l'enregistrement, le suivi et le controle qualite selon les besoins de l'etude.*
Partager la responsabilite des audits de controle qualite de la documentation des etudes cliniques (par ex. dossiers d'etude, dossiers CRF, dossiers de suivi, etc.) afin d'assurer une preparation constante a l'inspection.*
Faciliter et coordonner la commande, l'envoi et le suivi du materiel d'essai (par ex. CRF, carnets, fournitures de laboratoire, medicaments, classeurs d'etude, etc.).*
Aider les equipes projet a suivre l'avancement des essais en mettant a jour les systemes de gestion d'essais cliniques et en fournissant l'acces aux systemes d'etude/clients (le cas echeant).*
Executer, examiner et analyser les rapports d'etude pour en verifier l'exactitude et travailler avec les equipes projet pour garantir la mise a jour correcte des informations.
Aider a la coordination des paiements lies aux sites/etudes, le cas echeant.
Contacter et servir de point de contact pour les sites cliniques pour les demandes de base (par ex. mises a jour d'inclusion, documents manquants, organisation de reunions, etc.).*
Aider au suivi et a la distribution des rapports de securite.*
Coordonner la traduction des documents, si necessaire.
Aider et participer aux reunions d'equipe projet, preparer les activites correspondantes, rediger les ordres du jour et les comptes rendus.
Aider a la production de diapositives et supports visuels pour les presentations de projet, departementales, sponsors et/ou developpement commercial.
Aider a la coordination de divers rapports de suivi, y compris le suivi et la formation des membres de l'equipe.
Travailler en collaboration avec des collegues internes et externes pour atteindre les objectifs et les delais du projet.
Tenir informes le Chef de Projet / Directeur de Projet / Delegue des Operations Cliniques de tout probleme necessitant une attention particuliere.
Maintenir la confidentialite des clients et des patients.
Autres taches assignees.
Licence ou equivalent local en sciences de la vie ou discipline 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, 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 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
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.
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