Senior CRA: Sponsor‑Dedicated Site Monitoring

IQVIA Inc; Lombardia; On-site; EUR 34,000 - 67,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to perform site monitoring and management across Milan and Rome, ensuring study data and site activities comply with the protocol and regulatory requirements.

The role involves coordinating with sites for recruitment plans, providing protocol training, and maintaining documentation. Suitable for candidates with 3+ years on-site monitoring and CRA certification.

Qualifications

• Bachelor's and Master's degree in a scientific discipline or health care.
• At least 3 years on-site monitoring experience.
• CRA certification per Italian decree (Ministerial Decree)
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent written and verbal English communication.

Responsibilities

• Perform on-site monitoring visits (start-up, monitoring, close-out) per scope of work and GCP.
• Coordinate recruitment plans with sites to support predictability.
• Provide protocol training and maintain regular communication with sites.
• Evaluate site practices for adherence to protocol and regulatory requirements.
• Track regulatory submissions, recruitment, CRF completion, data queries, and study progression.
• Ensure site documents are filed and ISF/TMF maintained per regulations.
• Document visit findings and action plans with timely reports to the study team.
• Support project start-up and site management activities as needed.

Skills

GCP knowledge

ICH guidelines

Communication skills

Time management

Problem solving

Team collaboration

Regulatory knowledge

Education

Bachelor's and Master's in science or health care

CRA Certification

Tools

MS Word

MS Excel

PowerPoint

Laptop & mobile devices

Job description

IQVIA is seeking a Clinical Research Associate to perform site monitoring and management across Milan and Rome, ensuring study data and site activities comply with the protocol and regulatory requirements.

The role involves coordinating with sites for recruitment plans, providing protocol training, and maintaining documentation. Suitable for candidates with 3+ years on-site monitoring and CRA certification.