Clinical Research Associate Med Device
Il y a 2 mois
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.
**Context**:
The mission consists to set up clinical investigation centers and to monitor data collected in the framework of international pre or post-marketing studies in order to guarantee the quality and integrity of clinical data:
- Perform the selection and qualification of the investigational centers, the initiation, the follow-up and the closing of the clinical studies, in collaboration with the Clinical Study Manager or Clinical Program Manager.
- Ensure the monitoring and scientific, technical and regulatory quality of international studies according to ISO14155 and local regulatory requirements if necessary.
- To be in contact with the investigating doctors, and site staff for any question related to the study conduct
- Perform patient’s data review (including safety data) with the Data Manager and sponsor clinical team
- Identify non-conformities in the conduct of the study, and contribute to the implementation of corrective or preventive actions if required
- Contribute to the administrative tasks required to set up and monitor clinical studies (e.g. collection of documents from the center required for regulatory procedures, archiving the Trial Master File sponsor and center)
- Contribute to write (e.g. Trial Monitoring Plan) and implement study-specific clinical documents and monitoring tools
**Skills and Experience**:
- Excellent ability to work in a team
- Written and spoken English
- Scientific or quality training in the health field (minimum of 3 years of higher education)
- At least 2 years experience in the CRA function - Experience in ANSM/FDA type inspections appreciated
**Summary**:
- Type of job:
Full-time
- Location:
Boulogne-Billancourt, Ile-de-France, France
- Capability:
Clinical Research
**Contact**:
- Talent Acquisition Manager
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