Senior Clinical Research Associate (SCRA)
Core
Build and lead an in-house clinical monitoring capability for early-phase (Phase I healthy volunteer and Phase 1b/2a patient) trials at Quotient sites in Nottingham and Miami, establishing risk-based, inspection-ready frameworks.
Role type
Senior Clinical Research Associate (SCRA)
Builds
Risk-based, scalable, inspection-ready monitoring services and frameworks for Phase I and early patient trials
Domain
Clinical Trials / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Independent monitoring responsibility, ICH-GCP knowledge, early-phase trial conduct, external site/partner management, risk-based decision making, SOP development, deviation management, audit/inspection support, team mentorship
Preferred skills
Multi-site trial monitoring, inspection/audit involvement, process improvement, core clinical systems experience
Technologies
Clinical trial management systems (CTMS), electronic data capture (EDC), monitoring tools
Responsibilities
Conduct site initiation, routine, and close-out visits; develop monitoring plans and visit reports; manage deviations and corrective actions; ensure compliance with protocol and ICH-GCP; support regulatory inspections; mentor CRAs
Seniority
Senior, hands-on IC with leadership responsibilities