One of the most frequently asked questions I receive is how an experienced clinical research coordinator can own a clinical trial site. I have done many videos regarding this topic but here is a brief overview. If you need additional information, check out the various videos I have such as the one at the end of this blog post.
You will need an LLC or some other kind of entity to protect you. I have a client right now who is not using any entities but just a DBA, which is a fictitious business name, and everything is running through their social security number. That’s a quick way to get started and you will not have to pay a corporation fee.
If you are looking to cut down on costs, find the physicians with their own private practice and sell them on the idea of clinical research. Exceptional selling skills are extremely important. Many study coordinators are not good at selling; it’s a rare combination to have a good study coordinator who has good salesmanship as well. If you are not a good salesperson you have to develop that skill. This is an extremely important skill to have because you are going to have to convince the physicians that they should work with you and allow you to do research with them. You will need to convince them that you will be able to create extra revenues if they partner up with you. If you are able to get the physicians to work with you, an arrangement can be made to lower your start up costs. For example, instead of paying rent, you can pay the physician office a higher percentage of the gross revenues from the studies you get once you receive the payment from the Sponsor. Another advantage when you work with physicians is that they can also recruit patients for your study.
As far as licenses go, check with your local state laws. You will definitely need some type of CLIA waiver. If you partner up with physicians they may already have all of these necessary licenses.
Now, since you are a study coordinator, you don’t have to hire anyone else and have another salary as an extra expense. You will essentially work for yourself and without pay. It’s important that you are able to work without pay for at least 6 months (I’m being optimistic) and maybe even up to 1 year. Having no income will be very difficult, so it’s important to make sure you can endure the start up period.
As for equipment, you don’t need much to start up. At the minimum, you should have an exam table, ECG machine, centrifuge, weighing scale, etc. Again, if you partner up with a doctor’s office, it’s very likely that these items are already available to you. Check out this infographic for the bare minimum equipment requirements needed.
Lastly, do a clear and honest assessment of yourself and your skills (especially salesmanship) and your ability to work without a paycheck for around 6 months to 1 year. Do a self-assessment and contact me when you are ready to become owner of a clinical site, my consulting firms help research sites get off the ground and up and running!
