Freelance Senior Clinical Research Associate

Psi CRO; Lombardia; On-site; EUR 77,000 - 125,000; Full time

Job summary

Psi CRO is seeking an experienced Freelance Senior Clinical Research Associate to join our monitoring team in Italy. You will conduct site visits, ensure ICH-GCP compliance, manage site relationships, monitor timelines, and support TMF and regulatory submissions. Independent, highly organized professionals with 3+ years of on-site monitoring in Italy and English proficiency are invited to apply.

Travel within Italy is required; driver’s license preferred. Oncology experience is a plus.

Qualifications

• Requires degree in Life Sciences or equivalent.
• Minimum 3 years of independent on-site monitoring experience in Italy across multiple trials.
• Experience conducting monitoring visits in Phase I–III trials.
• Good command of English (written and spoken).
• Knowledge of ICH-GCP guidelines and trial regulations.
• Willingness to travel; valid driver’s license.

Responsibilities

• Preparing, conducting, and reporting on monitoring visits (site selection, initiation, routine monitoring, close-out).
• Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
• Maintain relationships with investigators and site staff.
• Monitor patient recruitment, study timelines, and site performance.
• Perform source data verification and data queries; manage site-level risks.
• Oversee investigational product accountability, trial supplies, and TMF reconciliation.
• Deliver site staff training and support regulatory submissions and audits.
• Provide guidance to less experienced CRAs; work in an international team.

Skills

Independent on-site monitoring

English proficiency

Travel willingness

Organizational skills

Communication

Problem solving

Team collaboration

Driver's license

Education

Life Sciences degree

Tools

MS Office

Job description

Freelance Senior Clinical Research Associate

Contract

We are the company that cares – for our staff, our clients, our partners, and the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives and bringing new medicines to those who need them.

We are looking for an experienced Senior Clinical Research Associate to start a freelance collaboration with PSI!

Responsibilities

• Preparing, conducting, and reporting on all types of monitoring visits, including site selection, initiation, routine monitoring, and close-out visits
• Ensuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
• Building and maintaining strong relationships with investigators and site staff
• Monitoring patient recruitment, study timelines, and site performance
• Performing source data verification, following up on data queries, and managing site-level risks
• Overseeing investigational product accountability, trial supplies, and essential study documentation
• Maintaining Investigator Site Files (ISF) and supporting Trial Master File (TMF) reconciliation
• Delivering study-specific training to investigators and site staff
• Supporting regulatory submissions, audit preparation, and resolution of audit findings
• Providing guidance and mentoring to less experienced Clinical Research Associates

Qualifications

• Degree in Life Sciences or a related field, or an equivalent combination of education, training, and experience
• Minimum 3 years of experience of independent on-site monitoring experience in Italy, ideally across multiple clinical trials
• Experience conducting all types of monitoring visits in Phase I, II, and/or III clinical trials
• Good command of English, both written and spoken.
• Experience supporting oncology studies is an advantage
• Good knowledge of ICH-GCP guidelines and clinical trial regulations
• Proficiency in Microsoft Office applications
• Strong organizational, communication, and problem-solving skills
• Ability to work independently and collaboratively in an international team
• Valid driver's license and willingness to travel to clinical trial sites

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.