Roles and Responsibilities of a Clinical Research Coordinator
In clinical research, it’s no secret that clinical research coordinators (CRCs) are tasked with an objectively high number of day-to-day tasks when managing any of their studies at any given time. Coordinators spend the majority of their time understanding informed consent forms (ICFs), communicating with the regulatory coordinators, managing subjects already on a protocol, and working heavily with monitors during their on-site visits. However, one of the biggest and most time-consuming tasks for CRCs surrounds study activation and learning protocols for each study they are on. This article will outline the challenges CRCs face, how they can better allocate their time to higher accruing studies, and understanding how to make their institution’s technologies work for them as they manage multiple studies.
Challenges of a CRC
It’s not uncommon for research teams to have a hand in a few different studies at any given time, and in the midst of juggling day-to-day tasks, the main challenge for coordinators is managing all of the protocol intricacies for each study. At any moment, the principal investigator (PI) could identify a potential participant on a different study than the one a CRC is currently focusing on. Study coordinators need to be ready at all times in case a situation like this were to happen.
Keeping a hand in every study and reviewing protocols every once in a while saves CRCs from scrambling to understand a protocol and poorly explaining it to a potential participant. Another major benefit of understanding a protocol is decreasing the chance of a protocol deviation. For example, knowing the timeline between screening a subject and putting them on protocol could be the difference between starting them on time and having to re-screen them. Taking a little extra time to review the timeline benefits study team members and the participants, and avoids any deviations, keeping them on protocol.
Allocating Time Wisely
With so many daily responsibilities, it’s especially important for CRCs to make sure they are making the best possible use of their time. By dedicating specific parts of a day to specific tasks, it allows coordinators to stay more focused on the task at hand without worrying about what’s coming up. If a CRC is on multiple studies at one time, it is also helpful to block out time each week to review studies coming down the pipeline. Reviewing eligibility criteria and ICF requirements early on will save CRCs time in the end. This will be especially helpful as these studies start to come to fruition, and a CRC needs to meet with a potential participant. Being aware of the study at hand will prevent any last-minute, rushed review of a protocol.
If a CRC is working on multiple studies, chances are at least one study is accruing less participants than the others. Oftentimes, a study that had the potential to accrue many participants falls short, and CRCs spend the bulk of their time, in hindsight, overpreparing for the protocol. For studies such as these, it’s important to be aware of the protocol without allocating time to it that would be better used on other, higher-accruing studies.
Utilizing Research Technologies to Its Fullest Potential
While utilizing research technologies may seem like an added step in some cases, it will almost always reap benefits for the study team. If a study team is involved in investigator-initiated trials (IITs), taking advantage of a CTMS can be very useful. Since the PI acts as the investigating sponsor in the study, everything happening on protocol that normally needs to be communicated with the sponsor is staying internal, the CTMS gives study staff access to all the data points. By using a CTMS for an IIT, the data is already in the system, which not only keeps study staff informed but keeps all of the necessary data in the same place.
In addition to an institution’s CTMS, leveraging other software pieces goes a long way, aiding in a CRC’s daily task list. For example, an eRegulatory binder helps keep documents and signatures housed in one place, easily allowing coordinators to access forms. In these electronic binders, there could be a repository of institutional review board (IRB) approvals for various protocols, up to date ICFs, and other necessary documents for continuing in the protocol.
Operational analytics also has been proven useful to study coordinators in their daily tasks. Users can track task lists and activation trends within a protocol. By doing so, they can see all the steps in the activation lists and understand how far along in each study they are. The operational analytics dashboard will allow coordinators and PIs to see averages on tasks such as IRB approval or contract negotiations. Seeing average timeframes on tasks such as these helps the CRCs and PIs better plan for accrual openings and overall study activation.