We are seeking a Senior Clinical Research Associate to lead the operational execution of global medical device clinical studies. Oversee complex investigative sites, ensure study quality, and manage operational risks. Ideal for candidates with significant clinical research experience and expertise in site management and regulatory compliance.
Skills
- clinical trial management
- site management
- ich-gcp
- site qualification
- site activation
- iso 14155
- fda regulations
- site performance monitoring
- protocol compliance
- data quality management
- risk mitigation
- etmf
- ctms
- edc
- investigator training
- study device accountability
- close-out planning
- tmf inspection
- regulatory inspection support
- audit support
- clinical quality standards
- mentoring cras
- process improvement
- risk-based monitoring
- acrp-cra certification
- acrp-cp certification
- socra ccrp certification
- class iii medical device clinical trials
- global multicenter studies
- fda ide/pma clinical studies
