Added
1 day ago
Type
Full time
Salary
Salary not provided

Related skills

ai edc etmf hipaa fda

πŸ“‹ Description

  • Run and manage Evvy's portfolio of clinical studies end-to-end in NYC
  • Own PI and site relationships; primary contact with PIs and clinical partner sites
  • Manage study operations; ensure sites have materials and shipping to labs
  • Co-lead site activation: site selection, contracting, training, monitoring
  • Manage IRB submissions and regulatory docs
  • Maintain clinical docs (protocols, consents, eTMF, EDC) for audits

🎯 Requirements

  • 5-7 years coordinating clinical studies across multiple study types
  • Multi-site or CRO experience; run studies across multiple PIs and sites
  • AI in clinical research; applying AI to protocols and site communications
  • Experience in women's health, OB-GYN, fertility, or microbiome
  • IRB submission experience (WCG/Advarra/central/local) and EDC familiarity
  • ICH-GCP, FDA, HIPAA knowledge; CCRC/CCRP/ACRP preferred

🎁 Benefits

  • Flexible PTO
  • $1K learning and development budget
  • Health, dental, and vision insurance, plus HSA plans
  • 401(k) plan (Roth and traditional)
  • Monthly team events
  • Paid parental leave
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