Clinical Research Associate

17 ago - Italia
Parexel

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From
clinical trials to regulatory, consulting, and market access, every clinical
development solution we provide is underpinned by something special - a deep
conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a
therapy that ultimately will vantaggi a patient. We take our work personally, we
do it with empathy and we're committed to making a difference.

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.

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 d

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