Key skills
Google Cloud PlatformGCPGoogle Cloud
About this role
Role Overview
- Develops comprehensive study plans/protocols, ensuring adherence to ISO/FDA regulatory requirements
- Supervises study sites and activities to ensure adherence to clinical study protocols
- Conducts site assessments and on-site/remote monitoring
- Ensures efficient organization and accessibility of study-specific materials/documentation
- Provides support, training, and guidance to study sites and investigators
- Monitors study progress and performance metrics
- Drives the development and implementation of process improvements
Requirements
- 5+ years' experience in Clinical Research within FDA regulated medical device/product environments
- Strong knowledge of ISO14155-GCP and regulatory requirements (ISO, FDA)
- Proven experience utilizing clinical trial applications including EDC, eTMF, and CTMS
- Strong understanding of reviewing clinical study data and / or monitoring study data
- Proven experience in Clinical site assessments, developing study plans/protocols, on-site/remote monitoring, close-out visits, and providing clinical support
- Must have a minimum of a Bachelor’s Degree in Life Sciences or comparable disciplines
- SOCRA Certified Clinical Research Professional desired
Tech Stack
- Google Cloud Platform
Benefits
- Competitive salary
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement