CRA/Site Monitor II
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About The Position
The Clinical Research Associate II/Site Monitor II will be responsible for data integrity, data quality and ensuring compliance with International Conference on 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 II 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). Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
