CRA / Sr CRA
Core
Monitor and manage clinical trial sites to ensure compliance with protocols, regulations, and patient safety standards.
Role type
Clinical Research Associate (CRA)
Builds
Clinical research programs for pharmaceutical and biotechnology companies
Domain
Clinical trials / Life Sciences
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, Site initiation and close-out, Source data verification, Investigational product accountability, Root cause analysis, Regulatory compliance (ICH-GCP), Clinical trial management systems (CTMS)
Preferred skills
Risk-Based Monitoring (RBM), Medical terminology knowledge, Therapeutic area expertise, Microsoft Office proficiency
Responsibilities
Conduct on-site and remote monitoring visits, Review source documentation and case report forms, Perform site management activities, Assess investigational product inventory, Identify site process issues and support corrective actions, Prepare monitoring reports and study documentation, Support regulatory inspections and audits
Seniority
Individual Contributor (Entry to Mid-level)