Marina Malikova, Ph.D., MSci, MA, CCRA, RAC- Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over fourteen 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 Ph.D. 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 micro-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. Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012. Dr. Malikova is a member of the Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.
September 11 2019
01 : 00 PM EST
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies and process improvement impl..