Clinical Research Associate II – Senior Clinical Research

🕒 il y a 1 mois

🇮🇹 Italie – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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• Ouverte depuis 42 jours.
• Les offres de cette entreprise sont généralement pourvues en 43 jours.
• Aucun salaire indiqué.

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CTI Clinical Trial and Consulting Services

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1001 - 5000 employés

Fondée en 1999

💼 Conseil

🏥 Santé

🧬 Biotechnologie

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services est une organisation de recherche sous contrat (CRO) à service complet qui offre l'exécution d'essais cliniques, une stratégie réglementaire, des services de laboratoire et bio-analytiques, la génération de preuves du monde réel et la gestion de centres de recherche pour les promoteurs biotechnologiques et pharmaceutiques. Avec une expertise couvrant les études de phase I à IV et des domaines thérapeutiques complexes (y compris les maladies rares, la thérapie cellulaire et génique, l'oncologie, la neurologie et la transplantation), CTI soutient la conception d'études, la gestion de sites, le recrutement de patients, la surveillance, la sécurité/pharmacovigilance, la biométrie et l'assurance qualité. Basée à Covington, KY, l'entreprise met l'accent sur des approches intégrées et centrées sur le patient et sur l'orientation réglementaire mondiale pour accélérer le développement et apporter des thérapies aux patients.

Description

• Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits • Complete site visit deliverables with quality and within Monitoring Plan timelines • Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Participate in required general and study-specific training • Participate in investigator, client, and project team meetings, including presentations • Create and implement subject enrollment strategies for assigned sites • Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials • Perform site management activities and provide ongoing site status updates to the Clinical Project Manager • Conduct remote monitoring according to the study-specific Monitoring Plan • Use systems and reports to track subject status, CRF retrieval, source document verification, regulatory documents, and investigational product • Assist with project-specific activities as a member of the Project Team

🎯 Exigences

• 3 - 5 years clinical research experience as a CRA or related profession • Life science background • Excellent knowledge in ICH-GCP and regulatory requirement • Fluent (at least Level B2) in spoken and written English • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits • Ability to complete site visit deliverables within timelines and according to monitoring plans • Knowledge of applicable regulatory requirements, SOPs, and ICH GCP • Ability to assist with or oversee study start-up activities, feasibility, pre-study activities, and site selection • Ability to collect, review, and track essential/regulatory documents • Ability to complete general and study-specific training • Ability to create and implement subject enrollment strategies • Ability to manage investigational product and trial-related materials • Ability to conduct remote monitoring and use systems and reports to track study data • Ability to participate in investigator, client, and project team meetings, including presentations

🏖️ Avantages

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and global giving opportunities • Work contributing to advancing medicine and developing life-changing treatments

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