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Expert Profile
Marina Malikova
Executive Director, Boston University School of Medicine
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
Trainings by Expert
Good Clinical Practices: Practical Applications and Implementation, Audit Preparation
Category:
Clinical Research
The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites
Category:
Clinical Research
Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance
Category:
Clinical Research
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
Category:
Biotechnology
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Category:
Clinical Research
Trial Registration and Results Reporting on ClinicalTrials.gov
Category:
Clinical Research