Program Description

Advanced Site Management: Finance and Productivity Enhanced Business Practices for Clinical Research Programs

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The topic of financial practices and business processes continues to be a challenge for clinical research sites. The purpose of this workshop is to assist Site Managers, Site Coordinators, and Research Associates in improving their skills and their understanding of the practical financial and business tasks related to clinical research. This workshop will focus on providing tools and techniques that the participants can immediately utilize to benefit their clinical research programs.

Objective: The goal will be accomplished through lecture, case study, practical application and hands-on experimentation facilitated by experienced clinical research professionals. Information and practical application recommendations will be discussed regarding all of the functions of the research site related to finance, productivity, budgeting, billing, and executive reporting.

Learning Objectives: Upon completion of this course the attendee should be able to:

  • Describe the role of financial management in medical research
  • Discuss current trends in the clinical research industry
  • Discuss the foundational principles required to build a profitable research site
  • Explain effective processes for implementing billing systems and assuring billing compliance including relevant CMS (Centers for Medicare & Medicaid Services) billing regulations
  • Demonstrate an ability to conduct billing analysis on research protocols
  • Describe techniques for assessing study costs and reviewing sponsor budgets
  • Describe tools to assist in clinical trial budget negotiation
  • Demonstrate an ability to calculate the complete cost of a research study
  • Demonstrate an ability to understand the contract negotiation process
  • Discuss revenue recognition models and tools
  • Describe methods for assessing study performance and revenue positions and for enhancing cash flow
  • Describe methods for managing research program accounts receivable and business office reporting requirements
  • Discuss issues and challenges related to managing expenses at the clinical research site
  • Describe methods of calculating the profitability of a clinical research program
  • Demonstrate an ability to develop a research budget
  • Demonstrate an ability to use spreadsheets in managing financial aspects of clinical trials
  • Describe issues related to reporting the results of a research program to executive management