Rome-Based Senior Clinical Research Lead II

Fortrea; Milano; In loco; EUR 48.000 - 63.000; Tempo pieno

Descrizione del lavoro

Fortrea in Italy is seeking a Senior CRA II to lead site monitoring and site management for clinical studies. You will ensure regulatory compliance, protect patient safety, and maintain study files, with travel as needed and potential local coordination responsibilities.

The role requires a strong background in clinical monitoring (5+ years), familiarity with SAE reporting, and excellent English communication. Based in the Rome area, with competitive salary.

Competenze

• University or college degree with 5 years in scientific or medical field; CRA certification preferred.
• Minimum 5 years of clinical monitoring experience.
• Thorough knowledge of regulatory requirements.
• Understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.

Mansioni

• Monitor and manage study sites including routine monitoring and close-out.
• Ensure informed consent and protocol adherence.
• Verify data integrity and monitor CRFs.
• Monitor data for missing or implausible entries.
• Ensure audit readiness at site level.
• Travel as required.
• Lead monitor for protocol or project when assigned.
• Training, mentoring and development of new employees.
• Coordinate Local Project Coordinator activities.
• Track SAE reporting and produce narratives.
• Negotiate study budgets with investigators and assist with agreements.
• Provide client liaison as assigned.

Conoscenze

Clinical Monitoring

SAE reporting

Regulatory knowledge

CTMS experience

Project coordination

Team supervision

Computer proficiency

English proficiency

Stakeholder communication

Formazione

Master's degree in scientific/medical field

CRA certification

Strumenti

CTMS

Microsoft Office

PC/Windows

Descrizione del lavoro

Fortrea in Italy is seeking a Senior CRA II to lead site monitoring and site management for clinical studies. You will ensure regulatory compliance, protect patient safety, and maintain study files, with travel as needed and potential local coordination responsibilities.

The role requires a strong background in clinical monitoring (5+ years), familiarity with SAE reporting, and excellent English communication. Based in the Rome area, with competitive salary.