Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation
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 across assigned studies, including CRF and query status, protocol deviat
📌 Assistant CRA (Milano)
🏢 Thermo Fisher Scientific
📍 Milano
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