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gcp edc informed consent clinical trials tmf📋 Description
- Monitor and manage clinical studies at study sites.
- Lead start-up, site activation, and ongoing monitoring.
- Prepare EC/IRB submissions and regulatory documents.
- Maintain trial management tools and status reports.
- Review IP handling and ensure protocol adherence.
- Travel up to 60% domestically and internationally.
🎯 Requirements
- 4-year college degree or equivalent in science/healthcare.
- Two+ years as a CRA in a CRO or clinical research.
- Excellent communication and organizational skills.
- Client-focused approach; strong teamwork.
- Experience with EDC, TMF/ISF, and IRB submissions.
- Able to travel overnight; up to 60% travel.
- English fluency; local language for non-English sites.
🎁 Benefits
- Paid time off and volunteer time off.
- Robust medical offerings.
- Non-vested 401(k) with company match.
- Paid parental leave.
- Discretionary annual bonus.
- Life and disability insurance.
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