Clinical Research Associate / Senior CRA (Remote, Kyiv)

About the role

PSI, a Contract Research Organization with 30 years in the industry, is hiring a Clinical Research Associate / Senior CRA for a remote position in Ukraine. You will carry out monitoring tasks on clinical studies across different therapeutic areas while working alongside experienced clinical research professionals.

Key responsibilities

• Prepare, conduct and report on all types of monitoring visits, including site selection, initiation, routine monitoring and close-out visits
• Ensure compliance with study protocols, ICH-GCP guidelines and regulatory requirements
• Build and maintain strong 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

Required profile

• MD, PharmD or MSc
• 1+ year of independent on-site monitoring experience in Ukraine
• Experience in all types of monitoring visits in Phase II and/or III trials
• Experience in oncology, ulcerative colitis or antibiotics trials is a plus
• Full working proficiency in English and Ukrainian
• Ability to plan, multitask and work in a dynamic team, plus communication, collaboration and problem-solving skills
• Willingness to travel