Clinical Research Coordinator 2
Core
Mid-level research professional managing routine-to-moderately complex clinical studies, data collection, and regulatory compliance for the Otolaryngology department.
Role type
Intermediate Clinical Research Coordinator
Builds
Clinical research studies and data sets for the University of Miami Health System
Domain
Healthcare / Clinical Research
Required skills
Clinical research protocol management, data management, chart review, regulatory compliance (ICH GCP, HIPAA), adverse event reporting, EDC/CRF completion, source documentation, ALCOA+ principles, stakeholder communication, risk analysis
Preferred skills
ACRP (CCRC/ACRP-CP) or SOCRA (CCRP) certification, CITI certification (GCP and Human Subjects)
Technologies
EDC systems, CRF systems, regulatory file management systems
Responsibilities
Perform chart review and pre-screening for study participant eligibility; coordinate routine clinical study activities including data collection and maintenance; perform moderate to complex research tests and experiments; observe and report adverse events; identify and report protocol deviations; maintain regulatory binders and training records; provide coaching and orientation to CRC 1 staff; support sponsor monitoring visits
Seniority
Intermediate, hands-on IC