30 oct
|
Fortrea
|
España
Fortrea seeks a Senior Clinical Research Associate II to oversee site monitoring and management for clinical studies in oncology, ophthalmology, and gene therapy. The role includes protocol implementation, data integrity verification, regulatory compliance, and leadership of monitoring activities across multiple sites based in Madrid.
Responsibilities
- Conduct routine site monitoring, initiation visits, and study close-out activities
- Verify informed consent procedures and protocol adherence at study sites
- Review source documents and case report forms to ensure data integrity and completeness
- Prepare trip reports, manage vendor relationships, and track serious adverse events
- Serve as lead monitor, coordinate clinical projects,
and present at investigator meetings
Requirements
- Bachelor's degree or allied health certification; or 6+ years clinical monitoring experience
- Minimum 5 years clinical monitoring experience
- Minimum 2 years experience in oncology, ophthalmology, and/or gene therapy
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and English, written and verbal
- Understanding of serious adverse event reporting and data management systems
- Ability to train, supervise, and mentor junior staff
📌 Senior Clinical Research Associate II (España)
🏢 Fortrea
📍 España