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 monitor clinical trial sites nationwide.
Role type
Home-based Clinical Research Associate (CRA) with training
Builds
Phase I-IV clinical trials for biotechnology, pharmaceutical, and medical device industries
Domain
Clinical Research / Clinical Trials (via careerplan.io/jobs/12935-clinical-research-coordinator-to-home-based-cra-clinical-research-associate-at-medpace)
Required skills
Clinical Research Coordinator experience, site monitoring, regulatory compliance (GCP/SOPs), data verification, adverse event reporting, patient recruitment assessment, Microsoft Office proficiency
Preferred skills
PACE® training completion, therapeutic area expertise, leadership potential
Technologies
Integrated 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 risk-based monitoring (on-site and virtual) to identify deviations; verify subject eligibility; ensure drug/device accountability; review adverse events and concomitant medications; assess patient recruitment and retention; complete monitoring reports and follow-up letters.
Seniority
Mid-level, hands-on IC