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Compliance In Focus
Posted by John Lehmann on Wed, Jun 13, 2012

From Clinical Research Coordinator to Monitor

New Path as MonitorThis blog was written by a newer monitor with IMARC Research.  This is her experience, and certainly not representative of all research coordinators and monitors.  We thank her for sharing this, and hope others who have made the similar transition will chime in with their experiences!

Everyone has heard the saying, “the grass is always greener on the other side”.  We have also heard, “Wonder what lies on the other side of the fence?”  Well, I have seen what is on the other side of the fence and I have seen the greener grass!  I came from the world of a research coordinator and I felt that there was no other role more involved in research than that of the coordinator.

But recently, my eyes were opened to a whole new world of research – that of a monitor.  As I embarked on my new career path as a research monitor, I truly was able to see what was on the other side of the fence.  The best phrase that I can use to describe the role reversal is that I wish I knew then what I know now.

As a research coordinator, I was geared toward carrying out various study tasks, making sure all the subjects were accounted for, and preparing case report formsMANY case report forms.  A coordinator is focused on enrollment numbers, and performing study visits within the protocol window while ensuring good clinical care for the study patients.  It sounds easy enough, right? In reality, tracking down subjects who have relocated without leaving contact information, or getting a subject to come for an appointment when you need them to can be a real challenge.  At many sites, the coordinator is the glue that holds the study together.  They are often the direct line of communication between the sponsor and the principal investigator as well as the sponsor and the IRB.  Most often, the coordinator bears the burden of ensuring that study visits and tests are performed on time and are completed per the protocol. 

Unfortunately, frustration is often associated with the role because we do not live in a perfect world.  Things happen:

  • Subjects do not show up for appointments
  • Lab tests are not completed within study windows
  • PI just happens to be on vacation during a study visit (which was scheduled months prior)

As a research coordinator, I always felt I was chasing my tail.  That’s when I decided to cross the fence and see what was on the other side, and embark on the path to becoming a medical device monitor.   I entered the realm of regulations, regulations, and more regulations.  From 21 CFR 50 spelling out the elements of a good informed consent form to 21 CFR 812 outlining the requirements of an IDE, my role in research was expanded by being aware and knowing the regulations and how the regulations guide good research.

 Throughout my training, it was stressed that a good monitor knows how to follow a “rabbit trail”.  In other words, a good monitor follows the paper trail which may lead down one path but then that path may lead to another path and so on.  By following the various trails, the monitor can make sense of documentation, or the lack thereof.  This trail often explains discrepancies in documentation, which if caught and corrected early can eliminate much distress for the entire study team.  A good monitor develops a good rapport with the study coordinator and should be a resource of knowledge and guidance during the conduct of the research study.  But we are taught to proceed down the rabbit trail no matter where it takes us and to guide the research team in performing good, sound research while adhering to the protocol and following all Federal Regulations.

So is the grass greener on this side of the fence?  I do not think that it is particularly greener, but it sure is a nice view.  I have grasped a wealth of knowledge in my short time as a monitor.  When I look back to my previous role as a research coordinator and then look at my new role, I wish I had the same knowledge then that I have at this moment.  As a coordinator, so many things that I was required to do, from meeting enrollment goals and study timelines, to the myriad of paperwork to be submitted to the IRB would have made so much more sense.

For those of you who made the transition from research coordinator to monitor, how was the transition?  Please share your experiences with us!

Photo Credit: Laenulfean

Topics: Federal Regulations, Clinical Research, Clinical Monitoring

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