Clinical Research Associate (CRA) - Madrid (Hybrid)
Core
Own site start-up activities for Spain, coordinating ethics committee submissions and regulatory documentation to ensure clinical trials start on time.
Role type
In-house Clinical Research Associate (CRA)
Builds
Clinical trial site activations and regulatory submissions for medical technology products
Domain
Medical devices / Clinical Research Operations
Deliverable
client delivery
Required skills
Site start-up management, Ethics committee submission coordination, Regulatory documentation preparation, Clinical trial timeline management, Stakeholder alignment, CTMS/eTMF system updates
Preferred skills
Trilingual (Spanish, English, German/Italian), Experience with Spanish Ethics Committees
Technologies
CTMS, eTMF
Responsibilities
Coordinate ethics committee submissions for Spanish clinical sites, Prepare regulatory documentation including informed consent forms, Manage regulatory timelines for site activation, Liaise with Regulatory Affairs and Clinical Trial Managers, Update trial management systems to ensure compliance
Seniority
Individual Contributor