Experienced Clinical Research Associate
Core
Conduct on-site monitoring visits for clinical research sites to ensure compliance with protocols, GCP, and regulatory requirements for drug and medical device development.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and medical device sponsors
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial monitoring, Protocol adherence, GCP knowledge, Regulatory document review, Adverse event reporting, Site qualification, Source data verification, Patient recruitment assessment, Investigational product accountability, Monitoring report generation
Preferred skills
Health or life science degree, Microsoft Office proficiency, Communication skills
Technologies
Microsoft Office, Electronic Data Capture (EDC) systems (implied via source data verification)
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits for research sites; Verify investigator qualifications and site resources; Review medical records and source documentation against case report forms; Verify eligibility of enrolled subjects; Review regulatory documents and adverse events; Assess patient recruitment and retention; Complete monitoring reports and follow-up letters.
Seniority
Mid-level, hands-on IC
