Clinical Research Coordinators (CRCs) play a crucial role in ensuring the research team is compliant to Good Clinical Practice (GCP). The most valuable asset to a CRC is time. In my experience as a Clinical Research Associate, I’ve observed the working patterns of several CRCs, and I’m not at all surprised at the high attrition rate, which, in turn costs a site valuable time and money to find and properly train a replacement.
CRCs are pulled in so many different directions daily – from assisting with the recruitment of subjects to updating several tracking tools for patient visit activity – the role can be very stressful and often times overwhelming.
What can be done to ease the demands of the job?
Streamlining operations can reduce stress and help CRCs to be more productive and efficient. This can be done with the use of an electronic Clinical Trial Management System (CTMS), which can automate several of the daily activities CRCs do on a daily basis. Below is a walkthrough of the tasks associated with study activity when a CRC uses one CTMS solution, Allegro.
- A CRC takes about an hour or two to set up the protocol in the CTMS. This is a one-time activity that is done at the beginning of the study.
- Based on the setup, once a subject’s first visit is marked as occurred, all the planned dates for the future visits are automatically generated and the calendar on the homepage is populated. The CRC no longer manually calculates the visit dates or creates a visit chart.
- The calendar lists all the subject visits that are upcoming for the next seven days along with the information of the protocol, the subject ID, the visit number, and the subject’s contact information, making it easy to give reminder calls to the subjects. The calendar lists the visits from across the protocols that a CRC is handling so that all protocol visits can be managed from one system instead of referring to multiple visit trackers.
- During the subject visit, the CRC enters very minimal data on a single page, just five fields, that take as little as 30 seconds to fill out. This in turn accomplishes several tasks that would take hours to complete manually.
- Protocol compliance information is provided in the context of the visit in the form of re-consent alerts, and protocol procedures are displayed in the exact order in which they need to be completed, eliminating the need to refer to a protocol prior to the subject visit.
- Using an integrated CTMS eliminates the need to maintain subject visit trackers and finance trackers, or check on lab supplies, or spend numerous hours on IP accountability calculations. It also helps in gauging the CRC’s readiness for a monitoring visit in terms of tracking CRF completion.
The numerous hours that are saved when a significant amount of the manual tracking is eliminated can be better used towards other tasks, such as source documentation, CRF completion and query resolution, IRB/EC submissions, maintaining the Investigator Site File (ISF), and more. Increased efficiency of CRCs with regards to visit management will mean more attention is given to other important study related activities, thereby, improving the quality of work at a site while creating a more manageable workload for CRCs.
CRCs are undoubtedly the unsung heroes of sites when it comes to doing what it takes to be compliant to the regulatory guidelines and GCP. When CRCs are given proper tools to effectively manage their work, their job satisfaction can increase tremendously and have a direct impact on the efficiency, quality of work, and also help greatly in reducing the turnover rate.
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