Clinical Study and Regulatory Specialist I
Core
Lead study and regulatory coordination from activation to close-out of clinical research studies/trials, ensuring regulatory compliance and managing study financials.
Role type
Clinical Study and Regulatory Specialist I
Builds
Clinical research studies and trials for cardiologists, cardio-oncologists, electrophysiologists, cardiovascular surgeons, and interventional cardiologists
Domain
Healthcare / Clinical Research / Cardiology
Required skills
Regulatory submissions, site qualification, clinical data verification, patient eligibility verification, TMF/ISF maintenance, study financial management, medical terminology, data collection and management
Preferred skills
Clinical Research Graduate Certificate, SoCRA/ACRP certification, statistical analysis software, TMF/ISF structures, study financials
Technologies
Microsoft Word, PowerPoint, Excel, data management software applications
Responsibilities
Prepare regulatory submissions to REB and agencies (FDA, Health Canada); manage site qualification and initiation visits; execute administrative tasks including ethics submissions and staff training; verify clinical data and patient eligibility; manage on-site/virtual monitoring visits; ensure regulatory compliance; manage study financials; maintain TMF/ISF; coordinate study close-out.
Seniority
Junior, hands-on IC
