Senior Clinical Research Associate
Core
Conducting clinical investigations for innovative medical device studies across Germany and Europe, ensuring compliance with regulations and GCP standards.
Role type
Senior Clinical Research Associate (Medical Device)
Builds
Clinical studies for medical devices
Domain
Medical device clinical research
Deliverable
physical/clinical work
Required skills
Site selection and initiation, routine monitoring, close-out visits, patient safety monitoring, data quality assurance, protocol compliance, regulatory submissions, risk management, investigator relations
Preferred skills
EU MDR familiarity, mentoring junior CRAs
Technologies
EDC systems, eTMF platforms
Responsibilities
Perform site selection, initiation, routine monitoring, and close-out visits; ensure compliance with ISO 14155 and EU MDR; monitor patient safety and data quality; manage study risks and enrollment challenges; support documentation and regulatory submissions; mentor junior CRAs.
Seniority
Senior, hands-on IC
