Clinical Research Associate

12 ago - Roma
Altro

Parexel FSP is hiring for two experienced CRA's at either the CRA II or Senior CRA level to join one of a large Sponsor’s in the EU.

Consulti la panoramica del ruolo qui sotto. Se è affidabile/a di possedere le giuste competenze ed esperienze, si candidi oggi stesso.
This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution
Some Specifics About This Advertised Role

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.




Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.
Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable
Who Are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What We Are Looking For In This Role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart. xysqume
Here are a few requirements specific to this advertised role

Bachelor’s degree in life sciences or professional deg

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