One of the first things I tell someone when they ask me about doing clinical research is to make sure they have a good study team, and a good study team starts with a good study coordinator.
The role of a study coordinator (also called a clinical research coordinator or CRC) can be highly varied or very specialized, depending on the site and how they have their research organized. I have worked in both settings, and in fact I cut my clinical trial teeth 20 years ago in the role of a CRC where I was responsible for basically every task in the execution of the clinical trial. Think I’m kidding? Here’s a list off the top of my head…
- Re-wrote the industry protocol for IRB submission.
- Drafted/edited ICF for IRB submission.
- Completed the IRB submission, answered IRB questions.
- Created all source documents for the visits.
- Pre-screened patients.
- Met patients in clinic, consented, screened.
- Ensured study drug/vaccine orders were placed properly.
- Collected blood and urine specimens.
- Processed blood and urine specimens (centrifuge, aliquoting).
- Packaged and shipped specimens.
- Met subjects for follow-up visits in clinic.
- Dealt with queries from the clinical monitor.
- Made calls to the medical monitor.
- Completed CRFs.
- Met with clinical monitor for monitoring visits.
- Called subjects for telephone follow-up, tracked subject schedules.
- Called external offices for medical records.
- Completed/communicated SAE reports.
- Trained other study staff (and non-study staff) on the clinical trial.
Now, not every study coordinator can do all of those tasks, but as a Principal Investigator a lot of those are practically impossible tasks to fit into their existing schedule. For this reason a study team often consists of people with diverse skills and roles – for example a study nurse for procedures and assessments, and a data manager for CRF data entry and query responses. It should be clear though that a lot of the front-line work that’s required for running a study site requires having a reliable and smart person on the study team as the study-coordinator. Because clinical research is so tightly regulated, you can’t afford to have someone who isn’t careful and thorough on the team. You can also see the advantages of having experienced and well-trained individuals in that role, so it’s perhaps unfortunate that the role of CRC is one that is notorious for being relatively underpaid (compared to the tasks and responsibilities expected of them…) and for having high turnover (about twice the national average, at 30%) and COVID made this worse, with rates as high as 60% for some research sites in recent years.
The salary ranges for a CRC are as low as 37k/year, but can get up to a little over 80k. Many CRCs have medical backgrounds and they tend to be the ones paid at the higher end (for example, nurses, nurse practitioners, or even physicians who perhaps are new to the US and looking for a way to get started). Some of them though are wanting to get started on their careers, and the CRC role is really just seen as a stepping-stone. The turnover therefore isn’t because it’s a bad job (it’s actually a really fun job in my opinion!) but simply because being a CRC is not usually anybody’s career goal! People move on to the clinical monitoring role for a pharmaceutical company or CRO, or start their medical career training, or simply move up the ladder at their specific institution. The skillset and experience that is gained from working as a CRC are in demand all over the world of clinical research. The trouble with this turnover is that there are study-specific things to know, which might be due to the protocol, or the drug, or the sponsor, or the workflow at the specific institution, and losing study staff who have been trained up and who are SO crucial to the study execution means that the new CRC who picks up the mantle has to be trained all over again.
It’s very important therefore to properly mentor and support the CRCs at a site. If they are overwhelmed, mistakes are more likely. The already high rate of turnover will only be made worse, which will in turn impact the other CRCs and ongoing research at that site. I have been informed on several occasions that sites have slowed down enrollment, or even paused their research entirely, because of a staff shortage in the CRC role. It’s absolutely a worthwhile investment to have enough staff on the team to provide backup coverage and support where needed, and to have a succession plan in place for when a CRC moves on. Careful documentation of study-specific needs are crucial, as is effective and regular study team meetings with all the staff. Even if you’re not working on a particular protocol, you never know when you’ll be expected to do the work because someone is out sick, or starts their new CRO job.
As an Investigator or site manager, it would be important to bake in this salary support to things like budget negotiations with sponsors, or FTE requests and expectations with an institution, and to support ongoing training and education for the CRCs so they feel valued and can advance in their chosen career. It really is a great way to enter the area of clinical trials, whether investigator-initiated or sponsored studies and I have zero regrets from my time on the frontlines.
I could probably write a short post (maybe even a long one!) on any one of the tasks performed by a CRC in their day to day job, but for now I hope this brief insight is enough to make people realized how important they are.
Nick Bennett MD 