CRA / Sr CRA
Core
Monitor and manage clinical trial sites to ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements while safeguarding patient safety and data integrity.
Role type
Clinical Research Associate (CRA) / Senior CRA
Builds
Clinical research programs for pharmaceutical, biotechnology, and emerging biopharma companies
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical trial monitoring, site management, ICH-GCP compliance, risk-based monitoring (RBM), source data verification, regulatory inspection support, clinical trial management systems (CTMS)
Preferred skills
Medical terminology, therapeutic area knowledge, root cause analysis, Microsoft Office proficiency
Technologies
Clinical trial management systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits; review source documentation and case report forms; perform site initiation, routine, and close-out visits; assess investigational product accountability; identify site process issues and support corrective actions; prepare monitoring reports and study documentation; support regulatory inspections and audits.
Seniority
Individual Contributor (IC), entry to mid-level