Dear Professor Mean, I run a clinic and have a company interested in having my patients participate in a clinical trial. They tell me that I need to have a clinical research coordinator. What is that, exactly, and how much would it cost?

A clinical research coordinator (CRC) is a person who provides much of the day-to-day operations in a clinical trial. The background needed for a CRC is highly dependent on the type of clinical trial(s) that you will be running. In general, a CRC needs

1. to have some experience with interacting with patients in a health care setting,
2. to understand human subjects protections regulations, and
3. to be comfortable with data entry and data management.

If you are expecting to run only a few clinical trials, then you might be able to train one of your existing staff members to take on the role of a CRC. It’s a great career move for the right person. You’d have to get them some additional training and give them release time from some of their current responsibilities. You should also consider offering them an increase in salary to reflect their greater responsibilities. All of this takes money. Some of this will be covered by the payments you will receive from company asking for your help on the clinical trial, but you might have to ask around for additional funding. Many health care organizations see participation in clinical trials as an important strategic goal and are often willing to support efforts like yours.

What sort of training would you need to get someone to work as a CRC? They need to have a strong working knowledge of the health care system, familiarity with medical terminology, and experience interacting with patients. Almost anyone working in your office, of course, will already have this.

They also need to understand all the regulations affecting research in general and clinical trials in particular. These would include

1. human subjects protections encompassed in the Belmont report, and the Declaration of Helsinki,
2. privacy protections provided by the Health Information Portability and Accountability Act,
3. the role of Institutional Review Boards in reviewing and monitoring research studies,
4. good clinical practice, as defined by the International Conference on Harmonization,
5. management of conflicts of interest.

If your health care organization is already active in research, much of this training may already be available for the person you want to take over CRC responsibilities. Given their deep involvement with the conduct of a clinical trial, you may wish to get additional training above and beyond what is required for other researchers.

On top of all this, a CRC must understand how to use case report forms. This may involve abstracting information from the electronic health record and entry of data into computerized databases systems like REDCap.

Many research studies get audited, and the CRC will be heavily involved with these audits. The CRC needs to know how to document his/her work to withstand such an audit.

The CRC should also be familiar with billing and contracting issues. Depending on what your clinic does, the CRC may need to understand the proper handling of hazardous materials and potentially infectious bodily fluids.

Instead of training someone already in your clinic, you might want to consider hiring someone from the outside. The cost of the new hire could be shared among several clinics like yours, because it would take a large number of clinical trials to justify a full-time CRC. Whichever way you go, you may want to work with groups like the Association of Clinical Research Professionals to better understand what a CRC needs.

ONE FINAL WARNING!!! The job responsibilities of a CRC are broad and diverse, so don’t try this without allocating the proper amount of resources to do the job well. Keep in mind that poor quality work done by an undertrained or unqualified CRC could leave you and your clinic liable to civil and criminal penalties (e.g., through violations of patient privacy). This is not an area you want to skimp in.