Clinical research consultant with 20+ years in trials
I am a medical doctor based in Ukraine, with over 20 years of experience in clinical research and pharmaceutical development.
My entry into research began in 2002, when I participated as a sub-investigator in Phase III studies while practicing as a physician. In 2006, I transitioned into the pharmaceutical service sector, joining a central ECG lab as an ECG / Holter reader with a focus on cardiac safety in clinical trials.
Since 2009, I have been working in international contract research organizations (CROs) as a clinical research associate (CRA), progressing through roles from CRA I to Senior CRA. In 2015, I became an independent clinical research consultant, supporting sponsors and vendors with monitoring, site management, regulatory affairs, and good clinical practice (GCP) audit assistance.
Career highlights
Medical doctor
I started out as a practicing physician and cardiologist. My transition to research began in the early 2000s with involvement as a sub-investigator in several large-scale clinical studies.
These early assignments helped me understand how clinical trials are designed and conducted, introduced me to documentation standards, and grounded me in the core principles of not only patient care but also patient well-being and safety.
Central ECG laboratory
In 2006, I joined GaniMed GmbH, a now-defunct niche CRO focused on cardiac safety. My responsibilities included ECG and Holter interpretation and analysis, primarily within thorough QT/QTc (TQT) studies.
The role provided my first exposure to the vendor side of clinical research. I worked on internal SOP development, staff training, and supported external validation processes. It was a practical introduction to how small service providers operate under competitive and resource-limited conditions.
CRO experience
Between 2009 and 2015, I worked with several major contract research organizations, including INC Research (now Syneos Health), Covance (now Fortrea), and Quintiles (now IQVIA). During this period, I advanced from CRA I to Senior CRA, progressively taking on broader responsibilities across clinical operations.
My work covered the full range of typical CRA functions: feasibility, site selection, regulatory and ethics submissions, all types of monitoring visits, and site close-out. I was involved in Clinical Trial Agreement preparation, budget negotiation, and oversight of site payments. I participated in investigator meetings, contributed to sponsor communications, and provided guidance to junior staff.
In my later roles, I operated with minimal supervision and reported directly to sponsors. I also worked within a risk-based monitoring model for a dedicated client, adapting to remote oversight tools and systems.
Freelance phase
Since 2015, I have worked independently as a clinical research professional, providing full-cycle support in clinical operations and quality oversight. My work has primarily involved Phase II–IV studies, with a focus on oncology and other complex indications.
I have been engaged in the full lifecycle of clinical trials, from feasibility and site selection to contract and budget negotiation, regulatory submissions, all types of monitoring visits, and ongoing quality oversight.
In recent years, my role has placed increasing emphasis on compliance and quality assurance. I have supported both sponsors and sites in risk-based monitoring, GCP audit preparation and conduction, documentation review, and remote or on-site quality assessments.
Typical tasks included reviewing trial records for protocol compliance, identifying data integrity issues, and contributing to the drafting of GCP audit reports and CAPAs. I have worked independently and in collaboration with lead auditors to ensure trial conduct aligned with sponsor standards and applicable regulations.
Availability
Site-based activities are currently suspended due to the war in Ukraine. However, I remain available for projects that require an experienced, independent contributor for remote clinical research contracts, particularly in feasibility, document review, audit support, and regulatory coordination.
For a full overview of services, see the Services page and the Portfolio page for examples of my previous projects.