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gcp smartsheet edc ich etmf📋 Description
- Oversee in-house CRAs and CROs for site activities
- Liaise with sites, sponsor monitoring, and study team
- Ensure monitoring deliverables meet SOPs, GCP, and KPIs
- Lead meetings with CRAs to share updates and best practices
- Oversee site qualification, initiation, monitoring, and close-out visits
- Travel up to 35% for All Hands and Phase 3 meetings
🎯 Requirements
- Bachelor's degree in a scientific or healthcare field
- 8+ years as CRA or related role in pharma/biotech/medical device
- 2+ years leading a team of CRAs
- CCRA certification or equivalent preferred
- Strong knowledge of ICH, GCP, and FDA regulations
- Experience with EDC and eTMF systems (Smartsheet, MS Office)
🎁 Benefits
- Culture based on CORE values: Caring, Original, Resilient, Egoless
- Fast-paced environment with opportunities to wear multiple hats
- Competitive compensation with base, bonus, equity, health and retirement benefits
- Three weeks PTO, two company shutdowns, paid sick leave
- Support for professional growth and development resources
- Regular all-hands, in-person meetings to build relationships
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