Greece Job Openings
Excelya
Clinical Trial Assistant
FULL TIME
August 19, 2024
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.
General Responsibilities/Tasks:
- Deeply acknowledges and strictly follows sponsor & Excelya’s SOPs, guidelines, and appropriate local and international legislation.
- Continuously informed with regards to any amendments or updates of the national / European 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.
- Performs the adaptation of informed consent as per national requirements.
- Responsible for collecting the initial package of essential documents required for site activations and preparing and Investigator Site Files.
- Managing the uploading of all required documents in client/sponsor TMF & and follows up on any TMF issues and ensures resolution within timelines.
- Actively involved to project teams in the shipment of SUSARs and other regulatory documents to IRBs and Regulatory Authorities.
- Able to coordinate the translation of documents to local language through approved vendors.
- Actively participated in the project team meetings.
- Holds a bachelor’s degree of Life Science.
- At least 2 years of working experience as Clinical Trial Assistant (CTA) or similar position.
- Excellent knowledge of English language (written and spoken).
- Strong communication and organizational skills.
- Detail oriented and strong time management skills.
- Excellent knowledge of IT literate.
Summary
-
Type of job:
Full-time -
Location:
Greece -
Capability:
Clinical Research
Contact
International Talent Acquisition Officer
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