Senior Clinical Research Associate

Excelya>Full-time>Senior Clinical Research Associate

Job description

Established in 2014, Excelya is a ‘people centered’ contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop-shop service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.
 

We are recruiting Senior CRAs to work as consultants in a large pharmaceutical company. 

Missions : 

The Senior Clinical Research Associate will be responsible for the following tasks

– Monitoring of international clinical trials on phases I to IV

– Selection of investigating centres, implementation and monitoring of clinical studies

– Ensure the scientific, technical and regulatory quality of international studies

– Contribute to the administrative tasks required to set up and monitor clinical studies

– Carry out monitoring and co-monitoring visits with local CRAs to ensure the quality of data collected, source documents and archiving of investigator documents

– Interpreting the information collected by the various study participants and contributing to the implementation of corrective or preventive actions if necessary

– Be in contact with the investigating physicians

– Reviewing clinical instructions where necessary

– Prepare centres and contribute to audits and inspections

– Write visit reports in English

– Ensure traceability of deviations encountered according to a CAPA procedure

Profile:

Higher scientific education (BAC+5)

– At least 3 years experience in monitoring international clinical trials in the pharmaceutical industry,

– A significant and recent experience in the field of the pharmaceutical industry,

– Knowledge of the following systems: IWRS, e-CRF, CTMS

– Knowledge of Risk-Based Monitoring (remote visit, CDM),

– Fluency in written and spoken English essential

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