Clinical Research Associate / Senior CRA
PSI CRO · Kyiv
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.
Job Description
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
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.