Clinical Research Associate Day-to-Day Activities and Pain Points
Many people are curious about what a clinical research associate's daily job responsibilities entail, including the common pain points that CRAs share.
16 November 2015
Many people are curious about what a clinical research associate's (CRA) daily job responsibilities entail, including the common pain points that CRAs share.
While I've never been a CRA myself, from my own experiences consisting of over 10 years of working with CRAs on a daily basis, in addition to several former CRAs that are currently business partners of mine on various endeavors, I do have knowledge on this topic and am somewhat qualified to share my opinion on the matter.
I recently interviewed a former CRA and will highlight some of her key insights in this blog post. You can also watch the entire video interview here.
Traveling to Research Sites
From my experiences in dealing with CRAs over the past decade, one of the recurring themes I hear about is the amount of travel required of them. In fact, in the interview I just conducted with a former CRA and now current research site owner Tiffany Bennett, excessive travel to and from Investigator Sites was the main reason for her becoming a research site owner. She highlights, “the frequency that you’ll [the CRA] be going to the site will depend on how many patients that site is actually enrolling. Depending on the protocol you’ve been assigned to, you may have more visits or may have less, but the goal is to have each CRA on site once a month, and on average each CRA is responsible for eight sites.”
Another common CRA challenge is workload. Contract research organizations (CROs) are experiencing increasing demand from the pharmaceutical companies that typically outsource aspects of the clinical development process. There is, in fact, a shortage of experienced CRAs in the marketplace, and this problem becomes magnified as more studies enter the development pipelines. As Tiffany mentioned previously, a CRA is typically responsible for around eight research sites for every protocol that they manage.
Ideally, you would want a CRA to solely focus on one study, but that is sometimes not the case as demand for CRAs may trump the supply. Tiffany relates, “ sometimes there are CROs that want to assign you [the CRA] to a lot of studies and when it comes to retaining the information that you need in order to be able to do your job the way that they expect you to do, is difficult when having a lot of protocols to monitor. They [CROs] feel that the more experience you have with this type of work, the more protocols you are able to handle and that’s not necessarily true. You simply can’t retain that much information.”
Activities Typically Completed Before a Site Visit
I will explain this process from my experiences on the other end of this relationship as the research site. We usually receive a monitoring letter in advance of our monitoring visit. A monitoring letter essentially documents what the CRA reviewed at the last monitoring visit, including whom they met with and what tasks were accomplished. Additionally, it typically lists what the site needs to complete prior to the next monitoring visit; such as action items or details that the monitor found at the previous visit that need to be corrected or answered. Some examples of these action items are any outstanding queries that need to be answered, or an issue with investigational product discrepancy or drug accountability. Further, it must be ensured that adverse events and serious adverse events are reported and documented properly.
The purpose of these letters is to show the FDA that the study is being appropriately monitored, as well as to make the Principal Investigator and study staff aware of any outstanding issues that need to be resolved. Tiffany again adds some color commentary here, “before going onsite you want to make sure the data [in the electronic data system] is entered. You want to check your follow up letters from your previous visits to make sure that the action items have been resolved by the site. You have to communicate all of these things to your story coordinator before getting there [at the site].”
Common Issues To Resolve At The Site
Principal investigator (PI) oversight, the amount of direct involvement a PI has in the conduct of his study, is an issue with the FDA, and therefore, also an issue with a CRA. Often, the CRAs end up spending a very small amount of time interacting with the PIs, and instead, spend the majority of their time dealing with the study coordinators at the site. Tiffany adds, “I think, one of my biggest pain points was probably the PI not being available when they [the site] knew that I was coming.” The major issue is having the coordinator serve as the main communication point between the CRA and the PI. As with all communication, a sentiment is better conveyed when it occurs directly from one individual to another. Unfortunately, many monitoring requests to the PI often get overlooked unless either the CRA is able to constantly remain on top of the issue, or the study coordinator is able to resolve the issue themselves.
The following are a few of the issues that CRAs may need to monitor when they are on site:
- Protocol deviations encountered at the site: Is the site adhering to the protocol?
- Informed consent process: Who is consenting the subjects? What is the process? Have the forms been signed and dated properly by all individuals?
- Data entry: Has the site entered all of their data? How quickly are they entering it into the system?
- Investigational product: Is the site distributing the study medication properly and safely? Are the subjects compliant with the study medication? Is the compliance being documented?
- Queries: Is the site answering queries in a timely manner?
- Enrollment: Is the site enrolling qualified candidates?
- Adverse events: Is the site properly reporting all adverse events? Are the serious adverse events being sent to the Institutional Review Board (IRB), and are they following up on them?
This is certainly not an all-inclusive list, but hopefully it gives the reader a better understanding of a what a typical CRA must encounter on a day to day basis. Stay tuned for my next post.
Dan Sfera is the CEO and President of The Clinical Trials Guru, LLC and DSCS Sweat Equity & Investments, LLC. Through these two companies Dan assists Sponsors and CRO's with Site Selection, Research Staff Training, Recruitment, Contract and Budget Negotiations and Business Development. Dan is also owner, partner and advisor for dozens of clinical research sites across the United States as well as Internationally. With a focus on marketing, finance and operations, he and his team have helped successfully launch many research organizations in the past 10 years.