Clinical Research Associate — I&I or Oncology (In-house)

Role: Clinical Research Associate supporting Phase I-III oncology trials, focusing on site monitoring, study startup, data oversight, and regulatory compliance. Responsibilities: oversee CRO/vendor monitoring, ensure protocol adherence, perform site visits, SDV/SDR, manage regulatory documents, coordinate study startup activities, and collaborate with cross-functional teams. Requirements: Bachelor's in life sciences, nursing, pharmacy; 4+ years clinical monitoring experience including 1+ on-site; strong knowledge of ICH GCP, FDA regulations; hands-on with EDC, CTMS, eTMF (Medidata Rave preferred); valid driver’s license and passport; 30-40% travel. HighValue: Oncology (solid tumor/hematology), Phase 1/2, RECIST 1.1, KPI dashboards, risk-based monitoring, sponsor oversight of CROs. WorkSetup: hybrid with Boston office (70% presence), travel required.