Oksana Korolova

I am a Certified Clinical Research 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. My 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

Independent consultant, Vancouver, Canada

Medical Advisor / Clinical Research Consultant, contract, freelance, 3/2025 – 9/2025

• Advised a neuroscience focused startup on medical affairs strategy, pre-clinical research planning, clinical trial start-up and regulatory pathways.
• Delivered training sessions for clinical research sites (Eastern Europe) on GCP compliance, trial start-up, and scientific engagement.

Qu Biologics, Vancouver, Canada

Director Clinical Operations (Contract), 9/2024 – 3/2025

• Directed clinical strategy and operations for a Phase 2 immunology trial (RESILIENCE Study).
• Increased patient enrollment rate 3-fold by optimizing site engagement and recruitment strategies.
• Acted as medical liaison with PIs, REBs, CROs, and DSMBs, ensuring effective communication and scientific alignment.
• Supported safety review, AE/SAE reporting, and statistical analysis discussions with investigators.
• Delivered protocol training and scientific updates to clinical teams.
• Successfully managed the transition of the Clinical Operations department during an active Phase 2 clinical trial (a Letter of Reference from the company CEO is available). 

Black Tusk Research Group, Vancouver, Canada

Senior Clinical Research Coordinator, 8/2023 – 9/2024

• Coordinated regulatory submissions, ethics applications, and site activation documents across neurology and infectious disease trials.
• Partnered with CRAs and clinical trial leads to resolve monitoring issues, track deviations, and maintain TMF quality.
• Strengthened PI and site relationships, securing the company’s first neurology study (IMVT-1401-2401) through engagement and advocacy.
• Supported feasibility and site qualification processes, ensuring readiness for Phase II/III study launches.

Medical Center “Dopomoga Plus”, Kyiv, Ukraine

Principal Investigator / Clinical Research Manager, 11/2018 – 12/2022

• Directed start-up, activation, and oversight for 7 global neurology trials (e.g., Roche, Merck, IQVIA, PPD).
• Managed an 8-member study team (sub-investigators, CRCs, nurses), ensuring timely regulatory submissions, contract negotiations, and ethics approvals.
• Consistently achieved top-tier patient recruitment globally in selected trials, recognized by sponsors.
• Participated in site initiation visits, PI training, and team supervision to ensure inspection readiness.

Main Military Medical Clinical Center (Neurology department), Kyiv, Ukraine

Medical Doctor / Clinical Research Project Lead, 10/2009 – 11/2021

• Led clinical trial oversight, site readiness, and protocol training for multi-site neurology studies.
• Acted as primary liaison with sponsors and CROs, ensuring alignment on start-up deliverables.
• Supported financial planning for site budgets, ensuring accurate forecasting and timely payments.

Main Military Medical Clinical Center, Kyiv, Ukraine

Medical Doctor, 6/2003 – 10/2009

Medical counselling and practical treatment of Neurology diseases. Clinical Research in the medical center.

Main Military Medical Clinical Center, Kyiv, Ukraine

Resident Physician, Neurology 6/2002 – 6/2003

Resident practicing in the field of Neurology, doctor under supervision. Part-time Clinical Trial Assistant.

EDUCATION / CERTIFICATION:

Shupyk National Medical Academy of Postgraduate Education (NMAPE), Kyiv, Ukraine

• Ph.D. in Medicine, Neurology (6/2003 – 10/2009)

National Medical University ‘O.O. Bogomolec’, Kyiv, Ukraine

• Doctor of Medicine (9/1999 - 6/2002)

Certifications 

• Advanced Medical Science Liaison and Medical Monitor Training & Certification - CCRPS, 2025
• ACRP-PM® (Certified Clinical Research Project Manager) – ACRP, 2025
• CCRP® (Certified Clinical Research Professional) - SOCRA, 2024
• CPI® (Certified Principal Investigator) - ACRP, 2024
• Advanced Clinical Research Associate Certification - CCRPS, 2024
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), 2023
• Health Canada Division 5 • Drugs For Clinical Trials Involving Human Subjects, 2023
• TCPS 2: CORE-2022 (Course on Research Ethics), 2023