Experienced CRA, Sponsor Dedicated - Italy

IQVIA

Pharmaceutical Research Industry

Roma - Italien

Director

Hybrid

Experteer Overview

In this role you will monitor and manage study sites to ensure protocol adherence, regulatory compliance, and timely data reporting. You work closely with sites to drive recruitment, deliver protocol training, and maintain open communication to manage expectations. You assess quality of site practices, escalate issues, and track study progress from regulatory submissions to data capture. You may support start-up activities and TMF/ISF documentation. This role supports cross-functional project execution and, when applicable, site financial and recruitment planning.

Responsibilities

Conduct site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP
Collaborate with sites to drive and track subject recruitment in line with project needs
Administer protocol training and maintain regular site communications to manage expectations
Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed
Track study progress: regulatory submissions, approvals, recruitment, CRF completion, data queries
Ensure site documents are filed in the TMF and ISF is maintained per GCP and local rules
Document site management activities, visit findings, and action plans; generate reports and letters
Collaborate with study team for project execution support; may assist start-up
May support development of per-site recruitment plans and site financial management as applicable

Key requirements

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
Strong knowledge of GCP and ICH guidelines
Therapeutic and protocol knowledge from company training
Proficiency in Microsoft Word, Excel and PowerPoint; familiarity with laptops and mobile devices
Written and verbal communication in English
Organizational and problem-solving skills
Effective time and financial management; ability to work with diverse teams

clear communication organizational skills problem-solving GCP and ICH knowledge CRA documentation (TMF/ISF processes)CRF tracking and data query resolution

Description

In this role you will monitor and manage study sites to ensure protocol adherence, regulatory compliance, and timely data reporting. You wor…

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