Clinical Research Associate
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
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 study sites, set up and monitor clinical studies
- Ensure the monitoring and scientific, technical and regulatory quality of international studies
- Perform investigational product ( IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administrated to the subjects / patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately re( labelled), imported and released / returned.
- Routinely reviews the Investigator Site File ( ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File ( TMF). Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- Contribute to the administrative missions required to set up and monitor clinical studies
- Carry out monitoring and co-monitoring visits with local CRAs 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 study investigators
- Revise the study sites if necessary
- Prepare the centers and contribute to the audits and inspections
- Write visit reports in English
- Ensure the traceability of the deviations encountered according to a CAPA procedure
Education and Experience
- Bachelor’s degree in a life science- related field
- A minimum of 1 or 2 years' experience in monitoring activities within the international clinical trials in the pharmaceutical industry
- Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory timelines
- Knowledge of the following systems: E-TMF, E-CRF
- A mastery of Risk-Based Monitoring (remote visit)
- Excellent communication , presentation and interpersonal skills
- Fluency in written and oral English essential.
Your application has been successfully submitted.
Excelling with Care