Related skills
gcp edc informed consent regulatory submissions ip๐ Description
- Oversees site management to protect patient safety and data quality.
- Guides audit readiness and supports audits and follow-up actions.
- Maintains trial tools, trackers, and status reports.
- Manages site start-up tasks: feasibility, recruitment, IRB/EC submissions, docs.
- Performs IP inventory, labeling, and dispensation per protocol.
- Conducts on-site and remote monitoring visits; prepares monitoring reports.
๐ฏ Requirements
- 4-year college degree or equivalent in science/healthcare.
- 2+ years CRA experience in a CRO or equivalent (site management).
- Excellent communication and organizational skills; team player.
- Ability to travel up to 60%, including international travel.
- Experience with EDC, IP tracking, ISF/TMF, and regulatory documents.
- Fluency in English; local language for non-English sites.
๐ Benefits
- Paid time off and volunteer time off.
- Comprehensive medical benefits and 401k with company match.
- Paid parental leave and disability coverage.
- Training and professional development opportunities.
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