About us Solutions Capabilities Therapeutic Areas Resources Careers Submit an RFP EN Clinical Trial Assistant (CTA) Excelya>Full-time>Clinical Trial Assistant (CTA) Job description Share on 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 800 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 journey. 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. To learn more about us, visit www.excelya.com Your responsibilities will include, but are not limited to: Deeply acknowledges and strictly follows Excelya and sponsors’ SOPs, guidelines and appropriate local and international legislation. Keeps himself/herself continuously informed with regards to any amendments or updates of the national submission requirements and procedures. Collects all necessary information and documents for the preparation of the clinical trial application and compiles the file for submission. Ensures the correct implementation of the application to the IRBs/IECs, National EC and Regulatory Authorities as well as the approval procedure by these bodies following up and tracking any necessary actions. Tracks and updates the contact details of National EC, Regulatory Authorities and YPE/ELKE. Tracks and updates country specific requirements regarding ICFs, insurance requirements etc. Prepares the contract between the sponsor and the Investigators or the external vendors (when applicable) and follows up the contract execution. Handles the financial issues of the study, including investigator payments, regulatory fees, according to the appropriate financial agreements and documents. Performs the adaptation of informed consent as per national requirements. Ensures all relevant trackers and Excelya Sharepoint libraries are kept appropriately up-to-date as required for each project. Prepares and negotiates the budgets and contracts with investigators and the relevant authorities. Is responsible for reimbursement of laboratory examinations and assessments to the Hospitals. Collects required documents from sites e.g. CVs, IEC approvals, Signed Application Forms and keeps trackers up-to-date Collects the initial package of essential documents required for drug shipment. Prepares and sends Investigator Site Files. Provides to sponsor or uploads directly all required documents in client/sponsor platform or TMF. Follows up on any TMF issues and ensures resolution within timelines. Assists project teams in the shipment of SUSARs and other regulatory documents to IRBs and Regulatory Authorities. Coordinates translation of documents to local language through approved vendors. Participates to the project team meetings. May undertake other tasks as they may be assigned from the supervisor that will concern Excelya. Profile: Diploma or University graduate with fluency in English Not required, secretarial experience in the clinical research area is a big plus Good communication and organizational skills, ability in handling documents, good writing ability, focus to detail, IT literate Summary Type of job: Full-time Location: Greece Capability: Clinical Research Apply for this job Contact Aias Katsaros Senior Talent Officer Similar career opportunities The highest quality CRO with the most comprehensive service coverage throughout Europe Contact Excelya 738 rue Yves Kermen 92100 Boulogne Billancourt +33 (0)1 46 20 74 50 Contact us Discover About us Solutions Capabilities Therapeutic Areas Careers Data Protection Notice Cookie Notice Legal Notice Newsletter By subscribing, you acknowledge that you have read our Data Protection Notice and that you wish to receive marketing communications from Excelya. We are social Excelya 2021. All rights reserved. EN FR Contact us Join us At Excelya, we use cookies to allow our users to navigate through our website, remember their preferences and for audience measurement. By clicking on “Agree”, we will also use cookies to track and analyze user behavior, allow interaction with social networks, and for targeted advertising. For more information, including on storage and third parties, please check ourCookie Notice Reject All Accept All Cookies Cookies Settings