Let’s be honest; clinical trial billing is complex. It is riddled with complex protocols, dual billing systems (third-party payers and sponsors/CROs), hidden costs, payment delays and lack of descriptions of payments received. Meanwhile, federal regulators are investigating fraud and abuse in systems fraught with user error. Accuracy in clinical trial billing is a necessity for site sustainability both financially and to maintain compliance with the Centers for Medicare and Medicaid. With the stakes so high for sites, how do sites find a skilled clinical research financial administrator?
The supply and demand numbers don’t look promising. We conducted a search of every combination of clinical research finance titles including: financial analyst, finance manager/director/administrator, pre-award, post-award, grants manager, Medicare coverage analysts, budget and contract coordinators, etc. Between October 2015 and September 2017, there were a total of two active candidates looking for jobs with a demand of 97 active job postings.
Below are a few ideas to help sites fill this crucial role:

  • Promote. Speicher reminded us that clinical research coordinators leave the industry due to lack of career advancement. This is an opportunity to enable coordinators to use their expertise, learn a new role, and stay within the organization. Coordinators know how to break down protocols, identify hidden costs, and estimate time and effort for each protocol requirement. Clinical research nurses have additional insight on comprehensive costs of procedures, such as missed lab costs that can come with a biopsy, and what is typically standard and routine care. Coordinators will need education and training on clinical research billing and compliance. These are available via webinars, workshops, conferences, and hired consultants.
  • Hire. The hiring pool includes billing coders, finance analysts, finance managers, CPAs, project finance specialists, revenue or collections professionals, and finance auditors. These individuals can learn about the clinical research industry through webinars, conferences, workshops, and intensive training. With the right focus, professionals from outside of clinical research can build upon the foundation of their financial acumen and standard healthcare billing regulations.
  • Outsource. Leave it to the professionals and outsource billing, budget and contract negotiations, and collections. Clinical research staffing organizations are also another resource should you want to find specialized staff and keep finance in-house.

Key soft skills to seek out in clinical research financial administration candidates include attention to detail, organization, negotiation skills, problem-solving, conflict resolution, customer service, and patience.
Even with a staff member in the financial role, compliance requires everyone being ready to contribute. Here are three tips:

  • Create a succession plan. Do not let one individual be the sole owner of your site’s financial knowledge! Ensure your site has up-to-date financial SOPs and shared knowledge.
  • Start from the beginning. When orienting new employees, be sure to include clinical trial finances as a key portion of your onboarding process. This will help new employees understand their role in site financial sustainability, establish accountability on timely entry into the clinical trial management system, and possibly spark an interest in a career in clinical research finance administration. New employees, regardless of their role, need to develop a relationship with the finance expert (or team) to ensure accuracy in budgets, contracts, invoicing, and problem-solving.
  • Include team members in reviewing the budget. This enhances communication, holds the team accountable to ensure that all costs are covered and time is estimated appropriately, and provides ongoing training for both the finance team and the clinical staff on new industry developments.

While clinical trial billing may seem like a daunting process to master, there are many options available to sites looking to get more focused on finances. The right financial team for your clinical research site is ready to make an impact; you might just have to get creative about keeping your team engaged!
Note: This article originally appeared in the December, 2017 edition of SCRS Insite: The Global Journal for Clinical Research Sites.

  1. Moran J, Stevens E. Statzel J. Navigating clinical trials billing: Are you compliant? Applied Clinical Trials. January 22, 2013.
  2. Career Builder. Supply & demand report: Financial analysts. Talentstream Technologies. 2017.
  3. Speicher LA. Fromell G, Avery S. et al. The crltlcal need for academic health centers to assess the training, suppcrt. and career development requirements of clinical research coordinators: recommendations from the clinical and translational science award research coordinator taskforce. Clinical and Translational Science. 2012:5(6):470-475.

About the Author
Molly has over 18 years of health care experience with specialization in oncology, research and health care administration. Now, Molly shares her experience and expertise with sites as a Medix Clinical Research Consultant.