Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)
Core
Transform a Clinical Research Coordinator into a fully resourced Clinical Research Associate (CRA) to conduct monitoring visits at research sites for biotech, pharma, and medical device clients. (via careerplan.io/jobs/11847-clinical-research-coordinator-to-home-based-cra-clinical-research-associate-at-medpace)
Role type
Clinical Research Associate (CRA) with home-based training
Builds
Clinical trial monitoring and compliance for pharmaceutical and medical device development
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Clinical Research Coordinator experience, site monitoring, protocol compliance, regulatory document review, adverse event verification, patient recruitment assessment, Microsoft Office proficiency
Preferred skills
PACE® training program completion, therapeutic area expertise
Technologies
Clinical Trial Management System
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Perform on-site and virtual monitoring to identify deviations; Verify subject eligibility; Review regulatory documents and ensure drug/device accountability; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Mid-level, hands-on IC