Oksana Korolova

WORK HISTORY

EDUCATION

ABOUT OKSANA KOROLOVA

I am a Certified Clinical Research Operations and Medial Affairs Leader with a strong track record of expertise in clinical research methodology, clinical development, medical affairs, and site management. I am an enthusiast of the safe and ethical application of AI in clinical research. I am the founder of the \"AI in Clinical Research\" LinkedIn group: dedication to excellence drives successful outcomes in complex clinical research initiatives. I have high-level knowledge in therapeutic areas, hold an international MD degree, advanced SOCRA/ACRP clinical research certifications, and PR status in Canada. SUMMARY- Medical Doctorate (MD) and PhD (Neurology); extensive clinical expertise and research experience in complex therapeutic areas- 16+ years of total experience in Clinical Research (academic and pharmaceutical study): 8+ years in global pharmaceutical Clinical Trials in various roles (Clinical Operation Director, Clinical Research Manager, PI, and CRC) and 6+ years in Clinical Research Management- Advanced clinical research certifications: ACRP Project Manager (ACRP-PM®), ACRP Certified Principal Investigator (CPI®), Certified Clinical Research Professional (CCRP® - SOCRA)- Therapeutic areas: Oncology (5 years), Neurology (14 years), Cardiology (6 years), Pulmonology (5 years), Rheumatology (2 years), Immunology (2 years), Infectious diseases (2 years), etc- Experienced in managing timelines, budgets, vendors, and CROs; overseeing protocol development, patient safety, data integrity, strategic planning, regulatory submissions (Health Canada, FDA), ethical submission, and compliance. Strong leadership skills- Managing trial execution through site initiation, enrollment, monitoring, team leadership, risk resolution, cross-functional team training, performance optimization, and mentoring- Addressing protocol and regulatory issues and ensuring high-quality site monitoring and oversight. Maintaining ICH-GCP and SOP compliance, ensuring readiness for audits and inspections and managing protocol deviation and safety event documentation- Monitoring trial master file quality, reviewing and updating EDCs, conducting cleanup activities and maintaining DSMB review and review milestones. Providing regular updates to sponsors and management, conducting team meetings and ensuring effective communication- Coordinating study closure activities, including data reconciliation and drug accountability- Proficient in EDC systems, IWRS, and eTMF platforms