RESUME

SKILLS PROFILE

CLINICAL DATABASES              Rave Medidata, REDCap, Oracle, Veeva Vault, Medrio, BioClinica.

CLINICAL OPERATIONS            Patient recruitment, patient follow-up, eCRF data entry, clinical data management, query management.

REGULATORY COMPLIANCE   ICH-GCP, FDA and EMA inspections, ethics communications, study protocol adherence.

WORKING LANGUAGES           English, Georgian, Russian.

OTHER                                        MS Office, Google Workspace, SPSS, digital content creation and marketing.

WORK EXPERIENCE 

2018 – 2024 Clinical Research Coordinator | High Technology Hospital Medcenter    

• Executed clinical trial activities adhering to local regulations, SOPs and trial protocols.

• Experience in more than 30 studies with the primary emphasis on Phase III Oncology Trials.

• Guided 2 Phase 3 clinical trials through stringent FDA and EMA inspections, ensuring full compliance with regulatory standards.

• Acted as a first point of contact for FDA and EMA inspectors throughout the GCP inspections.

• Coordinated and scheduled patient visits according to the protocol, followed-up with them via telephone, sending reminders for blood tests and different study visits.

• Coordinated monitoring visits with CRAs.

• Assisted study monitors during monitoring visits, granting access to source documents and site files per protocols.

• Recruited patients (under PI supervision) on an ongoing basis, successfully enrolling patients using patient tracking, database search, and public record search.

• Ensured compliance with regulatory requirements, study protocol and ICH-GCP.

• Managed electronic data capture (EDC) systems to maintain accurate and up-to-date patient and trial data.

• Conducted comprehensive data entry, and log completion to support trial integrity and regulatory adherence.

• Anonymized and uploaded patient CT, MRI, and bone scans to various imaging databases, including Calyx, BioClinica, and Medidata Rave Imaging.

• Ensured accurate and secure handling of patient imaging data in compliance with regulatory standards and database requirements.

• Ensured timely reporting of safety reports made by PI to sponsor/ethics committee.

• Responded to queries in a timely manner.

• Conducted internal audits on regular basis.

• Communicated and submitted essential documents and study notifications to IEC/IRB on an ongoing basis.

• Filed documents and maintained them in Investigator Site File, including training logs, ICF and temperature logs, etc.

• Tracked subject recruitment rates, screen failure rates and discussed potential improvements with the Principal Investigator and site staff.

• Established good working rlationship with all site members and CRO representatives including PI, project managers, CRAs, study nurses, etc.
   

Jun 2022 – July 2023 Customer Support Associate | Wise plc. (previously TransferWise)    

• Managed a high volume of customer queries

• Handled customer complaints, including those from customers with special needs, providing empathetic and effective resolutions.

• Addressed and resolved multiple cases involving customers breaking the terms of use, maintaining professionalism and adhering to company policies.

• Implemented feedback loops to identify common issues and streamline customer support processes.

• Assisted in training new customer support associates, sharing best practices and enhancing team efficiency.

• Received positive feedback from customers and management for outstanding service and problem-solving abilities.

Mar 2022 – Jun 2022 Growth Intern | Pensight inc.    

• Part-time position.

• Created engaging and high-quality content for Instagram and Facebook, including promotional posters and content creation handbooks.

• Streamlined customer experiences by optimizing user journeys and improving interaction points.

• Developed effective lead magnets to attract and convert potential customers, contributing to increased lead generation.

• Actively hunted for potential new customers, expanding the company’s customer base and market reach.

• Designed and implemented TikTok organic marketing strategies, enhancing brand visibility and engagement.

• Monitored and analyzed social media metrics to assess the performance of content and campaigns, making data-driven improvements.
   

Sep 2021 – Nov 2021 Strategic Communications Intern | American Councils for International Education

• Part-time position.

• Moderated social media content to ensure adherence to community guidelines and enhance user experience.

• Investigated emerging risks across the region, collaborating with cross-functional teams to develop and implement effective resolutions.

• Scoped scalable solutions to improve user support in the Georgian market and partnered with other regions to share best practices.

• Designed culturally appropriate social media content that resonated with diverse audiences and promoted international education programs.

• Utilized deep understanding of Georgian market geopolitical knowledge, cultural nuances, and minority communities to capture signals and insights.

• Targeted regional schools for international exchange program ads, leveraging language skills and cultural insights to optimize outreach.

ACADEMIA RESEARCH

Jun 2023 Price of Freedom: Understanding Willingness to Pay to Avoid COVID-19 Lockdown

                        Master’s Thesis for Corvinus University of Budapest | click here for more
 

Jun 2021 Lessons to Learn from Georgia: World's First National HCV Elimination Program

Bachelor’s Thesis for University of Debrecen | click here for more