Clinical Research Associate I
Core
Support clinical trial sites from study start-up through closeout to ensure compliance with protocols and regulatory requirements for diagnostic solutions.
Role type
Junior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for diagnostic products
Domain
Healthcare diagnostics / Clinical research
Deliverable
client delivery
Required skills
Site qualification and monitoring, Protocol compliance monitoring, Data quality review, Source document verification, Adverse event reporting, Investigational product accountability, Patient recruitment assessment, Regulatory documentation management
Preferred skills
Life sciences background, GCP knowledge
Technologies
Microsoft Office Suite
Responsibilities
Conduct site qualification, initiation, monitoring, and closeout visits; Provide training to investigators and site staff; Monitor protocol compliance and data quality; Review source documents and verify clinical study data; Ensure eligible participant enrollment; Manage study and regulatory documentation; Monitor investigational product inventory; Review adverse event reporting; Assess site performance regarding patient recruitment and retention; Prepare monitoring reports.
Seniority
Junior, individual contributor
