Contact information

You can get this candidate's contact information from https://www.work.ua/resumes/18553887/

Work experience

Clinical research associate

from 04.2022 to now (4 years 7 months)
Representative office of JANSSEN PHARMACEUTICA NV, Київ (Медицина, охорона здоров'я, аптеки)

- Conduct on-site and remote monitoring visits, including Source Data Verification (SDV) and Source Data Review (SDR), across global Oncology clinical trials.
- Work across Phase 0 and Phase III interventional and non-interventional studies, including randomized trials.
- Coordinate issue resolution between site staff, Data Management, vendors, and other functions; escalate issues when required.
- Track outstanding actions and follow up through closure.
- Communicate directly with Sponsor/Study Team regarding study-related operational matters and site issues.
- Support implementation of new processes and systems and coordinate related site retraining.
- Coordinate with vendors on study-related operational matters and follow-up activities.
- Identify, document, report, and follow up on protocol deviations and other site issues.
- Review informed consent forms and source documentation for compliance with protocol requirements, ICH-GCP, ALCOA principles, and applicable regulations.
- Track and follow up Serious Adverse Event (SAE) reporting, including reports, narratives, and required follow-up.
- Compile, review, and maintain regulatory documentation and support Regulatory Submissions.
- Collaborate with site staff and Data Management to resolve data queries and support data integrity in eCRF and other data collection tools.
- Review site-specific logs, delegation records, screening and enrollment documentation, and Investigational Product (IP) accountability records.
- Support audit readiness and perform site close-out activities.

Clinical trial assistant

from 11.2021 to 04.2022 (6 months)
Representative office of JANSSEN PHARMACEUTICA NV, Київ (Медицина, охорона здоров'я, аптеки)

- Maintained clinical trial trackers and study documentation and followed up on missing, expiring, or inconsistent documents with CRAs.
- Supported IRB/IEC submissions and contract preparation activities.
- Customized and distributed essential documents, trial materials, and study communications to investigational sites.
- Maintained Trial Master File (TMF) essential documents at country and site levels.
- Performed periodic country-level TMF Quality Control (TMF QC) reviews and followed up on findings through resolution.
- Participated in preparation of regular study activity reports.
- Prepared researcher payments, non-IP product payments, and related study documentation.
- Reviewed vendor invoices and supported document archiving.
- Coordinated distribution of study supplies, including laboratory kits and questionnaires, to investigational sites.
- Organized and coordinated study-related operational activities.

Gastroenterologist

from 05.2014 to 10.2021 (7 years 6 months)
clinic «Euromed plus», KCC of Radiation Protection of Kyiv Population, Київ (Медицина, охорона здоров'я, аптеки)

- Consulted patients and performed specialized diagnostic evaluations.
- Analyzed medical histories and diagnostic data to support clinical decision-making.
- Collaborated with other medical specialists, including oncologists.
- Maintained accurate medical documentation.

Education

Ukrainian Military Medical Academy

Gastroenterology specialization course, Київ
Higher, from 2013 to 2013 (less than 1 year)

Bogomolets National Medical University

Internal Medicine program internship, Київ
Higher, from 2008 to 2010 (2 years)

Bogomolets National Medical University

1 medical, Київ
Higher, from 2002 to 2008 (6 years)

Knowledge and skills

• Clinical Site Monitoring
• Site Management
• Site Close-Out
• Operational Issue Identification Escalation & Follow-up
• Cross-functional Coordination
• Sponsor/Study Team Communication
• Vendor Coordination
• Action Tracking & Follow-up
• Protocol Compliance & Deviation Follow-up
• Serious Adverse Event (SAE) Reporting & Follow-up
• Regulatory & Ethics Submissions
• Clinical Trial Documentation
• Trial Master File (TMF)
• TMF Quality Control
• Audit Readiness
• Investigational Product (IP) Accountability
• Data Query Follow-up
• Clinical Study Trackers
• Medidata — Electronic Data Capture (EDC)
• Clinical Trial Manage
• Medidata
• Veeva Study Portal
• Signant Health
• Safety Portal
• Labcorp Portal
• YPrime Study Portal
• Calyx
• DrugDev
• ATLAS
• Clario
• Teckro
• MyInsights
• Conducting negotiations

Additional information

Medical Doctor and Clinical Research Associate with 4+ years of experience in global Oncology clinical trials, including Phase 0 and Phase III interventional and non-interventional studies, including randomized trials. Experience across clinical site monitoring, site management, regulatory activities, site close-out, clinical trial documentation, and operational issue follow-up. Experienced in direct communication with Sponsor/Study Team and in supporting implementation of new processes and systems.