Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)
Core
Conduct qualification, initiation, monitoring, and closeout visits at clinical research sites to ensure compliance with protocols and regulations.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical Research / Clinical Trials
Required skills
Clinical Research Coordinator experience, site monitoring, protocol deviation management, regulatory document review, adverse event verification, subject eligibility verification, data source verification
Preferred skills
Risk-based monitoring approach, therapeutic area expertise, leadership potential
Technologies
Integrated Clinical Trial Management System, Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits; verify investigator qualifications and resources; review medical records and source documentation; monitor adverse events and concomitant medications; assess patient recruitment and retention; complete monitoring reports.
Seniority
Mid-level, hands-on IC
