Clinical Research Associate (Tbilisi, Georgia)

ИФАРМА
Москва Опубликовано 2 июня 2026
Зарплата не указана
Полная занятость1–3 годаДругое
Зарплата не указана

Описание

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.
Описание
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.

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