Clinical Trial Assistant
Secteur : Industrie du médicament humain Famille de fonction : Développement cliniquefvezzani@excelya.com
Créée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ». Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieus ...
Description du poste et des missions
- Excelya
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journ For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field.
We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
II. Mission
• Provide administrative and regulatory support for clinical trials (protocol, observation books, submission documents)
• Management of replenishment delivery of medical products to pharmacies
• In charge of preparing and sending documents to the centers
• Collaboration with partners and subcontractors identified on pro-jects
• Financial tracking
• Responsible and exchanges with foreign CRAs for the cleaning of TMF: Validation of regulatory documents, validation of the certificate archiving, adaptation of the TMF tracker. Responsible for harvesting latest regulatory documents CRFs and SEQs validation pages.
• Sends a list to the CRAs of the regulatory documents to be collected or corrected. Upon receipt of the closing documents, return to the ARCs if there are errors and missing docs. Help the CRAs to finalize the closings by contacting the centers and sending a closing letter and follow up. Deactivation of pharmacist accounts
• Bibliographic search, Writing the research protocol and analysis plan
• Establish the data collection tool
Profil souhaité
III : Profil
You have one year’s experience in an ARC or CTA position. You speak and write a professional English
