Senior Clinical Research Associate
Core
Conducting independent monitoring visits and managing investigator sites for innovative medical device clinical studies across Germany and Europe.
Role type
Senior Clinical Research Associate (Medical Device)
Builds
Clinical investigations for medical device studies
Domain
Medical Device Clinical Research
Deliverable
physical/clinical work
Required skills
Site selection and initiation, Routine monitoring, Close-out visits, Protocol compliance, Patient safety monitoring, Data quality assurance, Regulatory compliance (GCP, ISO 14155, EU MDR), EDC systems, eTMF platforms, Risk management, Travel management
Preferred skills
Mentorship of junior CRAs, Continuous improvement initiatives
Technologies
EDC systems, eTMF platforms
Responsibilities
Perform site selection, initiation, routine monitoring, and close-out visits; Ensure compliance with ISO 14155, EU MDR, and GCP; Monitor patient safety, data quality, and protocol adherence; Manage study risks and enrollment challenges; Support investigative product accountability and documentation; Contribute to regulatory submissions and clinical reporting; Mentor junior CRAs.
Seniority
Senior, hands-on IC
