Skip to main content

Office of
Executive Development

Clinical Research Finance

January 10-12, 2023

Location/Format: Virtual | Cost: $1,595
Early bird registration: $1,395


February 22-24, 2023

Location/Format: UH Campus, In-Person | Cost: $1,595
Early bird registration: $1,395


March 22-24, 2023

Location/Format: Virtual | Cost: $1,595
Early bird registration: $1,395

Instructor

Mary L. Veazie, MBA, CPA, CHC, CHRC

The purpose of this program is to prepare individuals for employment in the field of clinical research finance. Currently, there are resources available for healthcare and research administration professionals that cover limited aspects of clinical research finance. There isn’t, however, comprehensive educational sessions for professionals seeking to understand the financial aspects of clinical research. This program combines multiple sources of regulations and operational approaches melded together to provide the most relevant, and current information on the financial administration of clinical research studies. The use of case studies enables students to practice the concept(s) discussed during each session and will serve to reinforce the learning experiences.

Potential Audience

Healthcare organizations that participate in clinical research and pharmaceutical companies seek to hire personnel who possess knowledge of the financial aspects of clinical research. The current pool of potential hires who possess this particular business acumen is slim. Oftentimes, the shortage of personnel with this expertise exposes research organizations to risks that include, but not limited to, non-compliance with federal and state regulations.

When organizations hire personnel to fulfill the financial functions supporting a clinical research study, they typically spend three (3) to six (6) months educating and training these individuals. The lengthy training is due to the complexity associated with the financial operations of a clinical research study. This program seeks to close this knowledge gap and help prepare prospective clinical research finance professionals for a career in the field of clinical research.

Who Should Attend

  • Medical School students interested in clinical research
  • Accounting or Finance students (Undergraduate and Graduate)
  • Individuals interested in clinical research finance
  • Individuals currently employed in the clinical research industry

Course Description

Clinical research finance is an important function of the clinical research industry. It entails a full comprehension of federal regulations, budget development, and patient-based insurance billing. Understanding the financial aspects of clinical research has long been a challenge for many organizations, clinical researchers and all other individuals interested in a career in clinical research finance. This 3-day boot camp takes the participant through the clinical research financial life cycle using case studies and a review course in preparation for the assessment. This course will provide participants with a certificate in Clinical Research Finance and the knowledge and skillsets to perform clinical research tasks in a compliant manner; thus, setting the foundation for a successful career in clinical research.

The boot camp will focus on preparing participants for a career in clinical research finance. It will educate participants in the following areas:

  • The financial feasibility of clinical research studies,
  • Managing patient and sponsor billing,
  • Applicable regulations,
  • The nuances of insurance billing,
  • Medicare billing guidelines, and
  • Operational efficiencies and risk mitigation through a compliant clinical research billing (CRB) program.

Successful participants will receive a certificate in Clinical Research Finance and understand how to leverage study and patient data to maintain and enhance a comprehensive and compliant CRB program.

Learning Objectives

  • Discuss federal and billing regulations while building compliant clinical research billing program.
  • Describe the financial feasibility process and deciding to perform/participate in clinical research study.
  • Describe the creation of the Medicare Coverage Analysis (MCA), determining coverage of items and services and incorporating MCA into clinical trial budget.
  • Discuss integrating MCA into an electronic health record and managing patient and sponsor billing by leveraging system integrations and mitigating organizational risk.

Course outline

Day 1: Overview of Clinical Research Finance & Pre-Award Processes (8 hours)

  • Overview of Clinical Research Lifecycle (1 hour)
  • Financial Feasibility and Decision to Participate in Clinical Research Study (1.5 hours)
  • Creating a Medicare Coverage Analysis (MCA) — a step by step approach; Billing Regulation Review (2.5 hours)
  • Creating a Clinical Trial Budget — incorporating MCA (1.5 hours) Negotiating a Clinical Trial Budget (1.5 hours)

Day 2: Clinical Research Finance Revenue Cycle (8 hours)

  • Preparing to Enroll and Consent Patients, Creating Timelines, and Ordering Services (2 hours)
  • Patient Billing: Charge Review Process and Medical Documentation; Sponsor Billing (2 hours)
  • Study Close Out — Reconciliation Process and Ensuring All Payments Received (2 hours)
  • Review & Exam Preparation (2 hours)

Day 3: Assessment/Examination (2 hours)