Freelance Senior Clinical Research Associate

We are looking for an experienced Senior Clinical Research Associate to start a freelance collaboration with PSI!
As a Senior CRA at PSI, you will play a key role in ensuring the quality, integrity, and compliance of clinical trials across various therapeutic indications. You will act as the main point of communication between clinical trial sites and project teams, building strong relationships with investigators and site staff while ensuring the rights, safety, and well-being of trial participants.
Remote role in Milano, Italy
Your responsibilities will include:

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

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.
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.
Originally posted on Himalayas