A clinical research monitor wears many hats throughout their career. They may step in as a coordinator of people and processes, an overseer of clinical research, and an expert in document review. Depending on the day, the roles may look different for a clinical research monitor, which requires these professionals to remain dynamic and flexible in their day-to-day tasks.
At the Academy of Applied Pharmaceutical Sciences, students in our Clinical Research, Drug Safety and Pharmacovigilance Post-Graduate Diploma Program learn the essential skills required to enter the industry. Many graduates go on to play a vital role in protecting the public with their contributions to clinical research. They help to reduce the challenges around getting drugs to the market through careful attention to protocols and regulations. Continue reading to see what a day in the life looks like for those working as clinical research monitors!
General Roles Throughout the Course of the Day
According to the FDA, monitoring is defined as “the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”
In line with this definition, you’ll have to have a number of skills under your belt following your pharma courses that you can use as a clinical research monitor. On any given day, you can expect to be:
- Communicating with team members about the next steps
- Documenting and reviewing data and processes
- Paying close attention to detail at every turn
After pharma courses, it will be important to perfect your ability to assess documentation.
Effective time management skills here are key to ensuring that all documents have been reviewed in time for the next step of the clinical research process, and to ensure the seamless progression of your monitored project. Another important skill you’ll use daily as a clinical research monitor is prioritizing tasks of the highest importance to ensure the timely completion of deliverables.
Exploring On-Site Roles as a Clinical Research Monitor
Often, clinical research monitors travel to various locations, where they work on-site to monitor the procedures of a clinical research team and ensure regulatory compliance. Each site may have its own protocols and may capture data differently from other sites. This makes it important for the clinical research monitor to determine the site’s specific process as the first order of business.
Collaboration is key, especially when entering new sites for the first time.
Once the clinical research monitor has worked out the structure, function, and flow of the site, they will usually move into specifics. This includes going through patient consent forms, ensuring all documentation needs are met for the current stage of the clinical research, and collaborating with team members when necessary to fill in any gaps. The clinical research monitor usually spends the day assessing the use of technology, assisting the site with any suggestions for improvement, and revisiting documented data.
What to Expect Working Off-Site After Pharmaceutical School
When not traveling to various sites, clinical research monitors continue their roles at their workplace. The daily tasks here may include:
- The sorting, printing, and filing of important clinical research documents
- Writing reports of site visits
- Planning follow-up conversations with site managers
- Keeping up with standard operating procedures
The task at hand will likely be whatever is most pressing on that day. Often, you’ll need to balance and cater to the timelines of multiple studies or sites simultaneously.
As a clinical research monitor, your days on the job will be dynamic.
After you graduate from pharmaceutical school, you’ll feel confident in your skills to juggle the tasks of a clinical research monitor. Students at AAPS study, analyze, and learn from practical cases to immerse themselves into the industry. This real-world application gives students the experience they need to succeed in their roles post-graduation.
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