Sr CRA (Level II) FSO
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for pharmaceutical clinical trials.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation, data review (SDR/SDV/CRF), investigator management, audit readiness, mentoring
Preferred skills
Medical terminology, Clinical Trial Management Systems (CTMS), process improvement
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites for compliance and data accuracy; initiate and close out clinical trial sites; manage essential documents and file reviews; mentor junior team members; track trial status and generate progress reports; respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC
