Before I entered the clinical research industry, I met quite a few people who worked as “study monitors” or “Clinical Research Associates” (CRA) at Pharma companies. Majority of these people I spoke to enjoyed their work, seemed to have a cool job they did from home most of the time, and they were earning the ‘big bucks’ as opposed to my friends in Academia who were doing research for peanuts and had very limited opportunities to work their way up even with advanced degrees.

I won’t go into why academia felt so terrible of a career choice in that moment, but I do want to tell you what exactly a clinical trial monitor does in their day to day professional lives. Almost 5 years have passed since I entered the industry, and I actually worked with trial monitors on the studies I supported, I made close friends who are study monitors, I have gotten into heated arguments with study monitors as a CRC myself, and I am currently in training to get a certification on trial monitoring. What I have learned in these years is that a good chunk of what I thought about study monitors was true – they do have good pay, and often much better than than both academia and hospital/clinic ‘site’ level positions for clinical research. And yes they do get to do a chunk of work remotely from their homes. However, what I now know is that they also need to travel a lot, spend long and sometimes dreadful days working out of different sites where they don’t have their own office and don’t know people to figure out and provide oversight and guidance for site level staff. They do this, while navigating a complex web of “pushing them to meet trial targets” and “not annoying the PI/team too much” and ensuring their supervisors at the Pharma are happy with the outcome of their project budget, while still promoting trial integrity and meeting all regulatory requirements.

With all that I have to say about the day to day role of a Clinical Trial Monitor working for Pharmaceutical companies, I ended up making a video for you. I hope you will find it useful and as always feel free to comment below the video with additional questions or reach out to me directly by email (thebrownfeminist90@gmail.com). I also find that reviewing these crash course videos on my channel are an excellent way to prepare for job interviews for these roles in clinical research.

What is a clinical trial monitor?

A clinical trial monitor, also known as a “study monitor”, a “CRA”, or a “clinical research associate” is typically someone working for a pharmaceutical or medical devices company who is responsible for the proper training, support, and oversight of a clinical trial at a site (clinic/hospital) to ensure compliance with regulatory and state/national guidelines and standards. What this means is that the sponsoring company who have developed the drug of the medical device or tool would hire and select someone for this role to liaise between the company and the site which has been selected to perform the study trial on human subjects. Pharmaceutical companies don’t recruit the subjects themselves as it is not in their expertise and it would be unethical as well – so they go through a medical center or site where they partner with a medical doctor (known as the investigator) and their research team to recruit participants, conduct the experimental study, and provide the data back to the company for analysis and submission to the regulatory body for product approval to come to the market. The monitor’s job is to ensure every aspect of the study is done appropriately to meet the standards and quality required for high quality data, meet research ethics guidelines, laws etc.

Do all clinical studies have study monitors?

Not necessarily. It is most common to find trial monitors in high risk studies, such as a drug trial where a new drug has been developed and is being given to human subjects who may have potential side effects. The higher the risk the greater is the need for monitoring of the study to ensure everything is done correctly and properly documented. Many investigator-initiated studies (as opposed to pharma sponsored studies) have a lower risk study design, budget limitations, and fewer monitoring needs. Some studies are monitored only centrally by a central coordinator who virtually checks on data entered but does not visit all sites to ensure compliance of all study materials and documentations. Other clinical studies don’t have monitoring at all, such as studies based on patient chart auditors and retrospective data collection and analysis.

Understanding what they do:

Part 1: Site Selection & Study Initiation Visit (SIV)

This section is exclusively available on the youtube video.

Part 2: On-going monitoring & study monitoring visit (SMV)

This section is exclusively available on the youtube video.

Part 3: Study Close-out

This section is exclusively available on the youtube video.