Central Clinical Research Associate
Core
Primary liaison for Principal Investigators and site staff conducting rare disease registries, managing site selection, study start-up, remote and onsite monitoring, and data quality.
Role type
Central Clinical Research Associate (CRA)
Builds
Rare disease registries for Sanofi Specialty Care, Vaccines, and R&D functions
Domain
Clinical Research / Rare Disease Registries
Required skills
Site selection, regulatory document review, ethics committee liaison, contract negotiation, remote site management, data quality control, patient recruitment support, CAPA implementation, eTMF management, GCP compliance
Preferred skills
Experience with rare disease registries, knowledge of international regulations, stakeholder alignment, process improvement
Technologies
eTMF, eCRF, clinical trial management systems
Responsibilities
Conduct remote and onsite site visits (selection, initiation, routine, close-out), review site documents for regulatory submission, manage site contracts and insurance certificates, monitor data quality and resolve queries, ensure safety reporting and audit readiness, support patient recruitment and retention, coordinate with vendors and internal stakeholders
Seniority
Mid-level, hands-on IC