Bilingual French Clinical Research Associate

October 2

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. • Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. • The Site Monitor I will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).

Requirements

• A minimum of 1 year experience as a clinical monitor / clinical research associate with demonstrated experience of on-site monitoring. • Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice.