Related skills
gcp oncology ip management sdv crfs📋 Description
- Conduct periodic monitoring visits and review CRFs for quality.
- Perform source data verification and resolve data queries.
- Manage investigational products and study materials (IP, ISF, CRFs).
- Train site staff on all study procedures.
- Support site initiation visits and startup documentation.
- Ensure timely reporting of safety issues (AEs/SAEs/SUSARs).
🎯 Requirements
- University degree in scientific, medical or paramedical fields.
- At least 8 years CRA experience; on-site monitoring.
- Advanced oncology and early-phase trial experience; CAR T required.
- Strong GCP/ICH knowledge and regulatory compliance.
- Fluent English; proficient with MS Office (Word/Excel/Outlook).
- Eligible to work as 1099 contractor; willing to travel 70%.
🎁 Benefits
- Global CRO with career growth opportunities.
- Collaborative, supportive team environment.
- Exposure to sponsor-dedicated oncology trials (CAR-T).
- 1099 independent contractor role offering flexibility.
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