We are seeking a Clinical Research Associate to support the execution of global medical device clinical studies. You will manage clinical research activities, ensure regulatory compliance, and collaborate with cross-functional teams. Ideal candidates have experience in clinical research and site monitoring within a regulated environment.
Skills
- clinical study execution
- ich-gcp compliance
- site monitoring
- iso 14155
- fda regulations
- clinical documentation
- etmf systems
- ctms
- clinical trial management
- site activation
- investigator training
- study device accountability
- regulatory submissions
- risk escalation
- data quality management
- site qualification
- site initiation
- interim monitoring
- close-out visits
- tmf/etmf
- audit support
- cross-functional collaboration
- problem solving
- acrp-cra certification
- acrp-cp certification
- socra ccrp certification
- risk-based monitoring
- global multicenter studies
- fda ide/pma
- eu mdr clinical studies
