Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study. What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC). Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked. Some of the major responsibilities of the CRC are:
- IRB Submissions:
- They gather all the documents for submission to the IRB and maintain the copies for the Regulatory Study Binder. In addition, they ensure all requirements from the IRB are met while carrying out study activities.
- When it comes to figuring out budgets, who would know better than the CRC the standard of care that is used at the facility? It is this information that figures highly into the budget determinations, since oftentimes study requirements are outside of standard of care and are not paid by the study subject.
- Patient Interaction:
- CRCs are often the people that have the most contact with the patient. They are the “face” of the study to the volunteers. If they do not follow up with patients, many would be lost after the initial contact. It sometimes takes determination to get a study subject to return after the initial visit.
- Informed Consent:
- Along with the investigators, the CRC is vital in ensuring informed consent is obtained from the patient volunteers in accordance with the regulations.
- Monitor Liaison:
- The CRC is the liaison that meets with the study monitor, a direct line to the sponsor, to ensure the study is being carried out appropriately.
After reviewing this job description, one gets a real appreciation for the CRC. It’s also important to note that some CRCs not only carry out these duties, but are also working the floor as nurses, which is a lot to juggle! In an article from the University of North Carolina, also discusses how important and vital the Clinical Research Coordinator is in the progress of clinical trails.
At site visits it’s easy to see the results of good Clinical Research Coordinators and bad ones. Some are very well prepared, keeping the study requirements under control and all the documentation updated and in place. However, other coordinators are too busy to keep up with the demands of the job and still others can become burnt out from all the responsibilities. Some are new still learning their roles and need the monitors to guide them on their responsibilities. We learn to work with all types, and work ourselves onto their team to ensure the research is carried out appropriately. One thing is for sure: without a good, conscientious Clinical Research Coordinator, many Principal Investigators would not be able to deliver on the requirements of their regulatory responsibilities. CRCs can make or break a clinical study.
Have you found the engagement of the Clinical Research Coordinator, vital to the quality of the study? Please share some examples.