Clinical Research Associate

Excelya>Permanent Contract>Clinical Research Associate

Description de l'emploi

Excelya, one of the leading independent CRO in Europe.

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

Missions:

For our Turkish team, Accompanied by Project Managers, the Clinical Research Associate will be responsible for performing the following tasks:

• Monitoring of international clinical trials on phases I to IV

• Select investigator centers, set up and monitor clinical studies

• Ensure the monitoring and scientific, technical and regulatory quality of international studies

• Contribute to the administrative missions required to set up and monitor clinical studies

• Carry out monitoring and co-monitoring visits with local ARCs to ensure the quality of the data collected, source documents and archiving of investigative documents

• Interpret the information collected by the various stakeholders in the study and contribute to the implementation of corrective or preventive actions if necessary

• Be in contact with the investigating doctors

• Revise the clinical instructions if necessary

• Prepare the centers and contribute to audits and inspections

• Write visit reports in English

• Ensure the traceability of the deviations encountered according to a CAPA procedure

The role is based in Turkey.

 

Profile description

• Higher scientific training BAC + 5

• A minimum of 2 years’ experience in monitoring international clinical trials in the pharmaceutical industry,

• Knowledge of the following systems: E-TMF, E-CRF

• A mastery of Risk-Based Monitoring (remote visit),

• Fluency in written and oral English essential.

 

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