She began her career in ecology and animal science, but while en route to a related Ph.D., ended up as a supplemental research coordinator because of her knowledge of writing protocols and conducting research. She says:
"For a short time, I worked as a float research coordinator. I would go to departments that needed research coordinators. Along the way, I learned many different aspects of being a coordinator."
Many people just think, ‘oh, you just coordinate things,’ but there is so much more to it than that. We are the liaisons between all parties involved in a research study, including the patient, the pharmaceutical company and its clinical research office, the principle investigator(s) onsite, and regulatory bodies and related requirements including: U.S. Food and Drug Administration (FDA) regulations, Internal Review Board (IRB) requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
So, making sure all parties are being accommodated while following regulations can be quite challenging.
What I appreciate is, especially at Mayo Clinic, we keep the patient in the forefront. Studies are a constant balancing act between what is best for the patient and what needs to be done for the study.
The one thing I always strive for is that our patients never feel like a number. No patient should ever feel like a number, especially in research. I work really hard behind the scenes to try and make a research study feel easy for the patient, because they are already dealing with so much.
Our job [clinical research coordinator] is to make sure a patient not only understands the risk factors of trial participation, but to make sure they understand the integrity of the study as well. Consent forms are usually 25-30 pages long and filled with a daunting amount of details.
It is our job to make sure they don’t feel pressured to do a study. Then, we have to verify that the patient understands what he or she is signing up for. Everything in research is voluntary and the patient can stop the study at any time.
Coordinators often become the front line for patients because they feel more comfortable with us. We create relationships with a lot of our patients, especially in hematology, because we may see some of our participants over many years and sometimes on multiple trials. Getting to know participants helps the patient feel more comfortable and can increase the accuracy of the data collected in the study.
It is a bit different with hematology patients. Because patients may be facing such a rare, complex disease, often times, there are not many apprehensions about participating in a clinical drug study. One common concern is often travel. Another is how many visits and how often a patient has to be on-site.
In regards to hematology patients, they are the closest representation of altruism I have ever experienced as a coordinator. These patients, especially with rare diseases, are not always concerned with how it benefits them, but rather how it will help their family members or others who may get or express the disease.
A common misconception regarding all studies is that all travel and drug costs will be reimbursed. While this may be the true for some studies, it is not universal for all studies. That is an important part of each study I make sure to discuss with each patient thoroughly before consent. Because the consent document is so long and complex, we often revisit this topic multiple times during visits to help keep the patient informed throughout the study.
It is amazing to watch a drug go from phase I all the way through to FDA approval. It is also encouraging that when I started some of the rare diseases had little to no treatment, but now have multiple studies and trials advancing to FDA approval. It gets back to the altruism that many of the participants exhibit. The future generations will have far more treatment options as a result of patient participation and the clinical research they make possible.
Often times, it is the involvement of the family. Most families are incredibly supportive and want to meet the doctors and want it to be a learning experience. Their encouragement and involvement is a beautiful thing to see. The other simple answer is watching the drugs or study benefit the patient.
Excerpted from an interview with Croghan published on Mayo Clinic Connect, an online community for people to share experiences and find support from others like themselves.