We are looking for an experienced CRA based in Tbilisi or willing to relocate to Tbilisi, to support international multi-center clinical trials on behalf of our Serbian CRO, AIMI LLC.
The role is primarily remote, with regular on-site monitoring visits in Tbilisi.
What you'll do
• Perform the full on-site monitoring cycle across assigned Tbilisi sites, including source document verification against primary medical documentation
• Manage site communication and maintain compliant trial master file records
• Read, review, and interpret source records written in Georgian; facilitate accurate translation of primary medical documentation as part of monitoring activities
• Conduct site communication in Georgian to ensure clear and effective interaction with investigators, site staff, and clinical teams
• Lead and participate in key trial meetings in English (Investigator Meetings, status calls, vendor calls)
• Ensure protocol adherence and compliance with ICH-GCP, sponsor SOPs, and applicable local regulations
• Identify and escalate risks and deviations, contribute to CAPA, and support audits and inspections
• Collaborate cross-functionally with PM, DM, Safety/PV, Regulatory, and QA teams
What we're looking for
• 2+ years of CRA/clinical monitoring experience
• Professional proficiency in English (B2 or above)
• Professional proficiency in Georgian (C1–C2) — required to independently review primary source medical documentation written in Georgian and to conduct effective on-site communication with investigators and site personnel
• Ability to perform regular on-site monitoring visits in Tbilisi as per the study monitoring plan
• Medical or biomedical education is a plus
Nice to have
• Experience with audits, inspections, and CAPA processes
• Therapeutic area experience in cardiology
Work format Remote, with on-site visits to Tbilisi clinical sites as required by the monitoring plan.