Clinical Research Coordinator

il y a 2 semaines


BoulogneBillancourt, Île-de-France Excelya Temps plein
Missions

Crée les documents administratifs de l'étude

Constitue le dossier de soumission à l'ANSM et au CPP

Crée et met à jour les tableaux de suivi de l'étude

Passe les commandes de matériel nécessaire à l'étude

Réunit et expédie le matériel nécessaire aux investigateurs

Saisit les données dont elle est responsable dans les outils dédiés de suivi des Essais Cliniques (CTMS)

Gestion Documentaire

Constitue le « study master file » en coordination avec le chef de projet développement

Constitue le template ISF Investigateur et pharmacie en adaptant l'index aux spécificités de l'étude

Collabore étroitement avec les ARCS de l'étude afin d'assurer une gestion documentaire de qualité

Gestion Budgétaire

Assure l'établissement et le suivi des contrats et des conventions uniques

Saisit les bons de commande dans IBUYS

Assure du règlement des factures, des honoraires des professionnels de santé et des surcoûts hospitaliers avec le RPDDemande la création des HCP/HCOSupport Recherche Clinique

Formation à CTMS pour les nouveaux arrivants (ARC, GEC et RPD) en collaboration avec les ARC et RPD en poste

Formation et encadrement des nouveaux GEC


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