Experienced Clinical Research Associate, IQVIA Biotech
Pubblicato il 26-10-2026 - Iqvia in Monza
Overview
In this role you will monitor clinical sites to ensure study conduct aligns with protocol, GCP, ICH, and sponsor requirements. You will manage site communications, training, and issue escalation, and track regulatory submissions, recruitment, data collection, and TMF/ISF documentation. You’ll collaborate with the study team to support execution and may assist with startup and site recruitment planning. The position involves travel and close attention to quality, timelines, and regulatory compliance.
Retribuzione / Benefits health and welfare benefits
incentive plans may be offered
career opportunities
Responsabilità Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirements
Drive and track subject recruitment plans to fit project needs
Administer protocol training to sites and establish regular communication
Evaluate site practices for protocol integrity and regulatory adherence; escalate quality issues
Track regulatory submissions, approvals, recruitment, CRF completion, data queries; may support start-up
Maintain TMF/ISF documentation and ensure regulatory filing requirements
Create and maintain site management records, visit reports, follow-up letters
Collaborate with study team for project execution support
Support development of site-specific recruitment plans; may manage site finances and invoices
Requisiti fondamentali Experience in Pharma Industry or Clinical Trials environment
University Bachelor's and Master's in scientific discipline or health care
CRA Certification as required by regulations
Very good computer skills including MS Office
Excellent command of English
Organizational, time management and problem-solving skills
Ability to establish effective working relationships with coworkers, managers, and clients
Flexibility to travel
Driver’s license class B
strong communication
problem-solving
time management
MS Office proficiency
GCP/ICH knowledge (implied)
clinical trial documentation (TMF/ISF) management