Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Marina Malikova

Specifically, this webinar will be focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs).

Lack of fiscal forecasting and unspecified billing compliance practices associated with clinical trials increases the risks of fiscal audits. A risk-based approach requires not only a strategy but tools to define key indicators to measure specific risks.

In this web seminar, we will discuss strategies for covering true costs related to clinical research and distinguishing them from routine care charges, and providing methodologies to avoid false claims and/or wrongful billing.

Why should you Attend: Current best practices for research administration, billing compliance, development of policies, procedures and training in accordance with current regulations will be discussed.

Areas in which regulatory agencies has been most active will be included in this session: research billing compliance, conflict of interest, research misconduct, federal grants compliance, effort reporting, and compliance with human research protections regulations.

Knowledge gained upon completion of this webinar will assist your research organization in navigating and/or avoid issues with research conduct, enforcement of current policies and procedures, IRB audits, and inspections by regulatory agencies.

Areas Covered in the Session:
– Research Billing
– Medicare Coverage Analysis
– Human Subject Protection
– Conflict of Interest
– Best Practices for Research Administration
– Grant Management and Compliance
– Research Misconduct
– Implementation of Good Clinical Practices
– Policies, Procedure Development and Training

Who Will Benefit:
– Clinical Research Association(CRA)
– Clinical Research Coordinator(CRC)
– Clinical Research Scientist(CRS)
– Clinical Quality Assurance Auditor(CQA)
– Principal Investigator(PI)
– Biostatistician
– Data Manager
– Compliance Professionals
– Research Managers
– Billing Specialists

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 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.

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 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.