Clinical Research Associate / Senior CRA

PSI CRO

17h • Remote

About The Position

PSI is seeking a Clinical Research Associate to conduct monitoring activities for clinical studies across different therapeutic indications. The role involves maintaining high quality standards while collaborating with experienced clinical research professionals committed to quality, teamwork, and advancing clinical research. This is a remote role in Ukraine.

Requirements

• MD, PharmD, or MSc.
• At least 1 year of independent on-site monitoring experience in Ukraine.
• Experience with all types of monitoring visits in Phase II and/or III trials.
• 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.

Nice To Haves

• Experience in Oncology, Ulcerative Colitis, or Antibiotics trials.

Responsibilities

• Prepare, conduct, and report on 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level