At the site level, having a great working relationship between monitors and research coordinators can really make a difference in the performance of the site. To do this, monitors walk a fine line between being personable and relatable, but also being respected and trusted.
- Monitors are often considered the site’s partner, there to help and guide them (in addition to our other traditional monitoring duties) with regulatory compliance questions. A monitor should be able to form a relationship with a lot of different people from various backgrounds. When a research coordinator is unsure or seeking guidance and they feel the monitor is unapproachable, or if they feel the monitor is not knowledgeable, it may inhibit the coordinator from reaching out for assistance. As a worst case, this could result in a potential non-compliance or deviation.
- Monitors can build respect in the relationships by knowing their “stuff”, for example: Sponsor requirements in a protocol and agreements, the Federal Regulations, GCP, IRB (Institutional Review Board) policies, just to name a few.
- Monitors can build trust by always following through on what they say they are going to do. As a monitor, I want to set my sites up for success from the very beginning. I try to connect personally and also prove my knowledge and skills so that when an issue does arise we can face it together and resolve it appropriately.
In my experiences as a monitor, I have found that having a good relationship with a coordinator makes the process much smoother. When a situation arises, such as a newly discovered adverse event, and the coordinator is unsure on what to do next, I want them to call me. I am happy to walk the coordinator through the process and help them record the adverse event exactly how the Sponsor would prefer the first time. In addition, I always remind them to consider what their IRB requires for reporting events. In this way, adverse events are more likely to be reported correctly and promptly. It can help prevent queries from being generated, as well as to help to ensure proper reporting according to the IRB policies, and those in the signed agreement with a Sponsor. This is just one example of why I find it is worth the extra effort to form that relationship in the beginning.
There have been other situations I have been in where I felt the relationship with a coordinator played a role in getting things done. I have worked with coordinators who were not able to complete all of what was required of them for a particular study. In working with the coordinator as a teammate, we can chisel away at the requirements over time. I can help them prioritize the work to be done because I have a different perspective and an understanding for all that coordinators do (see our previous blog). Sometimes it is as simple as the coordinator doesn’t understand exactly why they are doing something. Helping them understand exactly why something is required, and who requires it, has a very positive result.
Not all of the things we have to do in a study are considered “fun” but often I find myself being a cheerleader for coordinators. I believe that an attitude is contagious, and when you have a good, positive attitude it definitely can have an impact on the people around you. Of course there are exceptions to the rule, as with anything, but I think that if monitors and coordinators alike put in that little bit of extra oomph into their relationships, together we can accomplish a lot!
As a monitor, or even as the sponsor, how do you form working relationships with site coordinators? What examples do you have where this has made an impact in your study progress? Please share your experiences!
Photo Credit: isbg6