Assistant CRA

21 ago - Roma
Thermo Fisher Scientific

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office
Job Description

What You'll Do

Study & Site Support

Complete assigned study and site management activities in accordance with the study task matrix.
Complete required study-specific training and become proficient in relevant study systems.
Provide in-house support for pre-study assessments and related activities.
Support the customization and maintenance of site-specific documentation, including informed consent forms (ICFs), as required.
Support remote review and collection of applicable site assessments and documentation.
Verify document collection and submission status and ensure site information remains accurate and up to date.
Support the collection, review, and maintenance of Essential Documents in applicable clinical systems.
Follow up on missing, incomplete,



or expired documentation and support resolution of outstanding document findings.
Site Coordination

Support investigational sites throughout study start-up, activation, ongoing management, recruitment, and close-out activities, as assigned.
Assist site staff with vendor qualification processes where applicable.
Coordinate requests for study system access for relevant site staff and support access maintenance throughout the study.
Follow up on required site staff training.
Coordinate and support logistics for investigator meetings and other study activities.
Support study and site supply management throughout the study lifecycle.
Maintain study and vendor trackers as assigned.
Study Monitoring & Data Support

Support ongoing remote review of centralized monitoring tools and study dashboards.
Follow up on missing study vendor data, such as ECGs, laboratory samples, and electronic diaries, as directed.
Perform reconciliation activities acros

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