Experienced CRA, Sponsor Dedicated - Italy

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 15.11.2011

Knowledge of GCP and ICH guidelines

Therapeutic and protocol knowledge provided by company training

Proficiency with Microsoft Word, Excel and Power

Point; use of laptop, i

Phone and i

Pad 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