Clinical Research Associate / Senior CRA

* 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

Qualifications
* 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
* Experience in Oncology/Ulcerative Colitis/Antibiotics trials is a plus
* Full working proficiency in English and Ukrainian
* Proficiency in MS Office applications
* Ability to plan, multitask and work in a dynamic team environment
* Communication, collaboration, and problem-solving skills
* Ability to travel

Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

Company Description
PSI is a leading Contract Research Organization with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.