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.
What we offer:
- Quick development and career growth – Senior/Lead positions and many more great opportunities to advance
- Competitive remuneration package
- Medical private insurance
The SSUS supports the project teams in administration, maintenance and coordination of all logistical aspects of clinical trials, according to ICH-GCP guidelines and applicable Standard Operating procedures (SOPs). The SSUS reports to the Line Manager and works closely with the responsible team for the project concerned in order to contribute to the effective and timely accomplishment of all logistical and administrative issues relevant to clinical projects.
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.