IMARC monitors are all over North America on a weekly basis traveling to a wide range of sites from the small community hospital to the large medical center that also serves as a teaching institution. What makes a periodic monitoring visit a Good Visit? To those in the medical field, they may determine a good visit by the notability or prestigiousness of the facility itself. To the general population in the outside world, they may say - destination. After all, who wouldn’t want to be monitoring at the site next to the sunny, beautiful beach in southern Florida versus next to the corn field out in no man’s land? If you ask an insider, a monitor, the response would sound something like- “That visit was great. The research coordinator – she (he) was a ROCK STAR!”
Unfortunately, there are some research coordinators who do not have a strong foundation based in the Code of Federal Regulations Title 21 due to lack of proper training. Others would like to be a Rock Star and have the knowledge but are spread too thin, as discussed in this previous blog.
So what does a research coordinator do to earn “Rock Star” status in the monitoring world?
- Knows, understands and abides by the components of the FAIR Shake – In order to work in the world of research that involves human participants, a strong knowledge of the rules and regulations is necessary. The FAIR Shake technique takes an otherwise complicated maze of requirements and breaks them down into four simple areas that can be applied to clinical research questions. Are you in compliance with:
F - Federal Regulations
A - Agreements
I - Investigational Plan (protocol)
R - Requirements of the IRB
- Engaged in the study – Having a research coordinator send an email to ask what to do when a patient is coming in for a follow-up visit outside of the visit window is better than weeks later going to the site and wondering what happened with the subject’s required follow-up visit. The coordinators that engage in the study by reading through the study material, understanding the requirements of the protocol and staying on top of the updates and emails from the Sponsor tend to maintain an open line of communication with the IRB, Sponsor and Monitor. The coordinators that stay engaged and maintain this open line of communication assist in assuring that the patients are safely being treated, documents are submitted properly and in a timely manner, and that items of concern are addressed promptly and questions are being answered accurately.
- Exceptional organizational skills – There is nothing better than walking into a site and the research coordinator hands over the Regulatory Binder or Investigator File and it is in perfect order! For a coordinator overseeing multiple studies, organization is a must. Having all the required, completed, study documents filed together in one place gives a good first impression as to how the coordinator is overseeing the study. By reading through all the filed submissions to the IRB and the IRB’s responses or acknowledgements, one should know exactly what is going on at the site. It should be like reading a story and being able to see the entire picture.
- Willingness to adapt and learn, with kindness – Amendments to protocols occur throughout studies when new information becomes available or to ensure the safety of patients. A Sponsor may require new documentation or additional training throughout the course of a study. Research coordinators have to be able to adapt to the ever-changing research world. Doing a certain task “because it has always been done that way” does not always work in research. Coordinators that take advice and correction with kindness instead of offensiveness is key to the learning curve. Sometimes not knowing or understanding something can cause one to take offense. Learning should be a part of everyone’s daily lives. If we are not learning then we are not growing.
- Knowing and caring about the patients involved – Research coordinators that are organized and engaged in the study know the enrolled patients. Talking with coordinators that really care about patient safety and know the patient can tell you all about the patient’s history and the present condition of the patient. A lot of times, he or she will know the family and can recall the entire consent process or follow-up visit. An established relationship with a patient says a lot about a health care provider.
Have you worked with a ROCK STAR research coordinator? What skills or characteristics does he or she possess that could help others improve their practices?
Photo Credit: AdamNF