Experienced Cra, Sponsor Dedicated - Italy
Pubblicato il 25-10-2026 - Iqvia in Milano
Overview
In this role you support multicenter clinical studies by monitoring site conduct, data integrity, and regulatory compliance to ensure study success.
You collaborate with sites to recruit participants, train staff, and manage issues, while coordinating with the study team for timely execution.
You will contribute to quality oversight, document management, and study milestones, helping to advance patient outcomes and scientific rigor.
This position offers exposure to global trials and cross-functional collaboration.
Responsabilità
Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP
Drive and track subject recruitment plans aligned with project needs
Administer protocol training and maintain regular site communication
Assess site practices for protocol adherence and regulatory compliance; escalate issues
Manage study progress: regulatory submissions, recruitment, CRF completion, data queries
Ensure TMF/ISF documentation is complete and compliant
Create and maintain monitoring documentation, visit reports, and follow-up letters
Collaborate with study team for project execution support
Support site-specific recruitment planning and, if applicable, site financial management and invoicing
Requisiti fondamentali
Bachelor's and Master's Degree in scientific discipline or health care
At least 3 years of on-site monitoring experience
CRA Certification according to Ministerial Decree dated
Knowledge of GCP and ICH guidelines
Therapeutic and protocol knowledge provided by company training
Proficiency with Microsoft Word, Excel and PowerPoint; use of laptop, iPhone and iPad where applicable
Strong written and verbal English communication
Organizational and problem-solving skills
Time and financial management skills
Ability to build effective working relationships
Organizational skills
Problem-solving
Effective communication
GCP and ICH regulatory knowledge
Clinical trial documentation and TMF management
CRF completion and data query handling