Senior Clinical Research Associate II - FSP Model - Italy
Fortrea
Fortrea seeks a Senior Clinical Research Associate II to oversee site monitoring and management for clinical studies in Italy. The role involves ensuring regulatory compliance, data integrity, patient protection, and leading projects of limited scope with potential line management responsibilities.
Responsibilities
- Monitor clinical sites including routine visits, closeouts, and pre-study initiations
- Verify informed consent procedures and protocol adherence for patient protection
- Review source documents and Case Report Forms to ensure data integrity and completeness
- Conduct quality control visits and serve as lead monitor for assigned protocols
- Track, report, and follow up on serious adverse events and coordinate with legal on study agreements
Requirements
- University degree with 5 years clinical monitoring experience or Master's in scientific/medical field with CRA certification
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in Italian and English, both written and verbal
- 5+ years clinical monitoring experience with advanced site management skills
- Ability to work independently, resolve problems, and train junior staff
- Strong SAE reporting knowledge and registry administration skills
Offerta di lavoro pubblicata 14 giorni fa
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