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gcp microsoft office fda regulations case report forms (crf) on-site monitoring📋 Description
- Monitor Phase I oncology trials; remote 1.0 FTE; ~70% travel.
- Stay updated on scientific, regulatory and operational aspects.
- Support site selection, initiation visits, and startup documentation.
- May act as Feasibility Associate.
- Train site staff in study procedures.
- Conduct monitoring visits and ensure CRF data quality.
🎯 Requirements
- University degree in scientific, medical or paramedical disciplines.
- 8+ years CRA experience; strong oncology background.
- Phase I oncology monitoring experience required.
- On-site monitoring with SDV and CRF review.
- Fluent in English; proficient in MS Office.
- Willing to travel 70%; U.S.-based contractor (1099).
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