As a Clinical Research Associate II/ Senior Clinical Research Associate 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.
Hybrid role in Sofia, Bulgaria
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