Freelance Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate conducting site monitoring and ensuring ICH-GCP compliance for PSI’s global clinical trials. Supporting investigators, trial documentation, audits, and participant safety.
Responsibilities:
- Prepare, conduct, and report on site selection, initiation, routine monitoring, and close-out visits
- Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
- Build and maintain relationships with investigators and site staff
- Monitor patient recruitment, study timelines, and site performance
- Perform source data verification, follow up on data queries, and manage site-level risks
- Oversee investigational product accountability, trial supplies, and essential study documentation
- Maintain Investigator Site Files (ISF) and support Trial Master File (TMF) reconciliation
- Deliver study-specific training to investigators and site staff
- Support regulatory submissions, audit preparation, and resolution of audit findings
- Provide guidance and mentoring to less experienced Clinical Research Associates
- Act as the main point of communication between clinical trial sites and project teams
- Ensure the rights, safety, and well-being of trial participants
Requirements:
- Degree in Life Sciences or a related field, or an equivalent combination of education, training, and experience
- Minimum 3 years 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
Benefits:
- Further development of skills
- Opportunity to widen therapeutic area experience
- Opportunity to become an expert in clinical research
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