Clinical Trial Coordinator
Il y a 2 mois
Proclinical recrute plusieurs CTA qui travailleront dans les bureaux des clients, en combinaison avec le bureau à domicile. Ce poste est un contrat de 6 mois (renouvlable). Localisation : Liége Le CTA est chargé de fournir un soutien (administratif, logistique et gestion des documents) dans la préparation et l'exécution de toutes les activités liées au procès dans les délais convenus. Le CTA doit s'assurer que la documentation de l'essai est complète conformément aux procédures opérationnelles normalisées (SOP), aux bonnes pratiques cliniques (BPC) et aux exigences réglementaires applicables.
**Responsabilités**
- Soutenir le(s) CRA(s) et PM(s) avec tous les aspects de l'administration pour assurer le bon déroulement de l'essai.
- Pour configurer le Trial Master File (TMF) et le Investigator Site File (ISF).
- Aider à la préparation et à la collecte de documents d'essais cliniques essentiels.
- Agir en tant que propriétaire du TMF et conserver tous les documents essentiels requis dans le TMF, y compris l'examen périodique des dossiers pour s'assurer qu'ils sont complets, la préparation des audits internes/externes, le rapprochement final et l'archivage.
- Coordonner la commande et le suivi des matériaux d'essai et l'expédition des fournitures aux sites et surveiller les niveaux d'approvisionnement de l'étude.
- Coordonner la traduction des documents.
- Suivre, traiter et débloquer les paiements aux sites en collaboration avec l'équipe d'essai et le service financier.
- Pour assister aux réunions de l'équipe de projet et générer des procès-verbaux de réunion.
- Effectuer les soumissions aux comités d'éthique et aux autorités de réglementation : soumissions initiales, notifications, modifications et informations de sécurité, entre autres.
- Aider les ARC à préparer, effectuer et rendre compte des visites de sélection, d'initiation, de surveillance et de clôture des sites.
- Travailler, dans la mesure du possible, de manière proactive/anticipative pour éviter que des problèmes ne se produisent.
**Expérience requise**
- Une première expérience en Recherche Clinique (minimum d'un an).
- Maitrise du Français, Anglais et Dutch.
- Excellent relationnel.
- Expérience en eTMF (e.g., Veeva Vault) avec CTMS et eCRF.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
LI-RZ1
Clinical
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