As a Clinical Research Associate at PSI, you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will be collaborating with experienced clinical research professionals who are committed to quality, teamwork, and advancing clinical research.
Remote role in Ukraine
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