Clinical Research Associate - Sponsor dedicated - Hungary
Core
Monitor clinical trial sites to ensure adherence to protocols, regulations, and sponsor requirements, managing site performance and data integrity.
Role type
Clinical Research Associate (monitoring and site management)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Clinical research
Required skills
Site monitoring, subject recruitment management, protocol administration, regulatory compliance (GCP/ICH), data query resolution, TMF/ISF management, financial management, therapeutic knowledge
Preferred skills
Bachelor's degree in scientific discipline or healthcare, IT literacy
Technologies
Trial Master File (TMF), Investigator's Site File (ISF), Case Report Forms (CRF)
Responsibilities
Perform site monitoring visits (selection, initiation, monitoring, close-out), drive subject recruitment plans, administer protocol training, evaluate site quality and integrity, track regulatory submissions and enrollment, manage site documentation and visit reports, support project execution and financial management
Seniority
Entry-level to Junior, hands-on IC
