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Should My Site Hire A Regulatory Specialist?

Sites struggle with when to add specialists and when to have well-rounded clinical research coordinators doing everything. This former Regulatory Specialist talks about the pros and cons of hiring a dedicated regulatory specialist.

Dipti Pradhan
Dipti Pradhan
When you should hire a Regulatory Specialist versus when you should hire a Coordinator.
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A Typical Day in the Life of a CRC: Wearing Too Many Hats

Wearing Many Hats

A clinical research coordinator's day often begins at 7 or 8am as they prepare for the patient visits. A typical screening visit can last two or more hours and, depending on how busy the site is, a CRC could see up to three patients throughout the day. Each patient presents a different problem. There are patients who show up too early or too late, patients who claim they "never do drugs" while refusing to give a urine sample, and patients who forget their diary or medication or both.

Let's say you're lucky and your study is less complex, so all your visits are going smoothly (although this almost never happens). You would have some time in-between visits to make reminder calls to patients, schedule study visits or outpatient imaging visits, process lab samples, and prepare for upcoming monitoring visits. If there's a monitoring visit that day and you're the prime CRC, forget about getting these small, but numerous, tasks off of your plate. You will spend most of your time between study visits taking care of the CRA's queries.

After the visits, you have to transcribe all data collected insource into the sponsor's EDC system, as most sponsors have data entry deadlines of 3 working days after visit completion. Data managers raise queries that you have to answer in a timely manner. If your site doesn't have a dedicated enrollment specialist to pre-screen from the patient database, this job would also be done by you--the CRC who wears many hats. Calling patients to see if they're interested to be in a study is a challenging task as some people who don't want to be bothered and can be very rude on the phone.

Don't forget the samples you processed--they need to be shipped out in time. There is a contract and budget that you need to review, but you can take care of that some other day. You push a few other tasks to next week-- ordering supplies, drafting that 1572 and CV, getting that Sub-I's signature on the delegation log after they just left for the day (you forget they're on vacation the next couple of weeks). So you smile and think "Not Bad!" You have managed to get most of the admin work done in addition to your study visits.

But wait.

Now you realize you forgot to submit that periodic review report to the IRB--a task you had pushed to this week and whose deadline was a few days ago. So technically, your site's IRB approval has expired. It is way past 5 pm on this Friday evening and no one at the IRB will take your call.


Option for a Smaller Research Site: Admin Day

Planning Binder

If you are a small site with a few CRCs, each CRC wearing, of course, many hats, occasionally you can allot "admin time" or an "admin day" for a single CRC during the week. It would allow the CRC to get all of the admin work off his/her plate while the other CRC?s cover their patients. Each CRC would pick one day every week and, ideally, by the end of the month, everyone would be all caught up with their paperwork.

At a small site with low enrollment studies, this process works. But as enrollment increases on even one of the studies, this "Admin day" best practice would stop working for you. Sites are very competitive when it comes to recruitment, they have to do their best to enroll subjects before the enrollment window closes. At some point, you will need all your CRCs to enroll and screen subjects and admin work would once again take a back seat. Same thing would happen if the number of studies at your site goes up.

Medium or Large Research Site: Enter the Regulatory Coordinator/Specialist


If you are a medium-sized clinical trial site conducting multiple high-enrolling studies, the "Admin day" practice is not even an option. It is a good idea to hire a regulatory coordinator to take all Admin work off of the CRC's plates. Regulatory coordinators would be mainly responsible for maintaining Investigator Site File (ISF) or regulatory binders, making submissions to the IRB, completing regulatory documents like 1572s, and staying on top of all training required per the delegation of duties. The regulatory coordinator also ensures everything is audit-ready at all times.

Regulatory coordinators could order supplies or take care of invoices. You could even have your regulatory coordinator stay on top of data entry to alert CRCs that are running behind.

Perhaps the most important feature of the regulatory coordinator is their knowledge pertaining to local and FDA regulatory guidelines. CRCs are not up to date on current local and FDA regulatory guidelines, they solely rely on the monitors to guide them. However, there are some local regulations that you will need to know--e.g. a state law may require a researcher's controlled substance license in addition to a DEA license or a mandatory annual IRB visit. It is very important to have someone on site that is up to date on all regulatory requirements.

Most CRCs are familiar with good documentation practices, but they are prone to making mistakes on forms such as the 1572, financial disclosure etc., since this paperwork is not their specialty. As a result, mountain of paperwork on your coordinator's desk keeps going up as they receive sponsor/CRO queries.

An experienced regulatory specialist will come with deep knowledge of the regulations, experience working with CRAs from different sponsors, a strong sense of organization, and an intuition on how to deal with various requests. A strong regulatory specialist can even protect the staff from unreasonable demands by less experienced CRAs who themselves may not be familiar with the regulations.

If you are doing even 10 or more studies a year, and you are enrolling well, your CRCs are probably wearing too many hats. Occasionally, things are going to slip through the cracks and as a result, your studies will be full of errors that will only come to light during a monitor visit. Or, your site will have a high CRC turnover giving rise to more problems. At this point, it is wise to hire a regulatory specialist.