Serhii Kulish

Background

About Serhii Kulish

Dynamic and results-driven Senior Clinical Research Associate (CRA) with over nine years of experience in the clinical trials field. Specialized in conducting trials for various diseases, particularly in the fields of oncology, pulmonology, and cardiology. Experienced in the process of site selection for sponsors. Since 2022, I have been working in Poland, currently holding the position of Senior CRA at ICON Strategic Solutions. In June 2024, I successfully passed the state exam for knowledge of the Polish language for foreigners (level B1). Proficient in performing all types of visits, including selection, initiation, routine, and closing. I am fluent in Ukrainian (native), russian (fluent), and proficient in English (intermediate) and Polish (B1 level). Well-acquainted with the principles of Good Clinical Practice and regulatory documents (ICH-GCP, GLP, GMP), which form the basis of any clinical trial. I hold a valid ICH-GCP certification until 2027. Experienced in using the following systems: CTMS, EDC (Medidata, eCaseLink), eTMF (Veeva v1.0 and V2.0, PhlexEview), IXRS (4G Prancer, Endpoint, Almac, S-Clinica), and IRT (Suvoda). Skills: Clinical Trials Implementation and Monitoring Investigational Site Management Data Verification and Accuracy Team Leadership and Mentoring Regulatory Compliance (ICH-GCP, GLP, GMP) Strategic Planning and Coordination Multilingual Communication (Ukrainian - native, Russian - fluent, English - intermediate, Polish - B1) Systems Proficiency (CTMS, EDC, eTMF, IXRS, IRT)