Connections Quarterly

Clinical Research Coordinators (CRCs) are vital to conducting clinical trials as they must be thoroughly trained in the requirements for ethical human clinical research, especially concerning pharmaceutical and medical device treatment modalities. CRCs utilize advanced nursing assessment and research skills in the conduct and coordination of clinical research. The Clinical Research Coordinator is responsible for delivering the highest quality clinical research services to research patients while ensuring safety and adherence to study protocols.

I had no notion of what it meant to be a Clinical Research Coordinator when I started working as an autologous bone marrow transplant staff nurse over 19 years ago. The concept was daunting to say the least, however, it was monumental to know that I would be part of clinical research that offered new treatment alternatives to patients who had exhausted all other treatment options at standard care levels. This realization changed my attitudes about research tremendously and I actively sought an opportunity to become a clinical research coordinator.

Clinical Research is comprised of four phases:

Phase I:

Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II:

The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III:

The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV:

Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

When patients are enrolled in a clinical trial, their care is coordinated across several subspecialties. Clinical research patient care is managed by a team of physicians, nurses, radiologists and potentially surgeons or Radiation Oncologists as in the case of Oncology research. Generally, research coordinators are responsible for screening potential research subjects, obtaining informed consent, scheduling tests and procedures and dispensing study medication all under the direction of the Principal Investigator who is the physician responsible for all patients enrolled in that clinical research trial.

My own clinical research career has been very diverse to date and words cannot express the honor and amazement I feel in seeing commercially available treatments as a result of clinical research studies I have worked on as a research coordinator. To know that there are now treatment alternatives for patients as a result of all of the countless hours spent completing reams of paperwork is immeasurable.

That said, we have only gotten to where we are now because of each individual patient who participated in clinical research. Most importantly, to those of you who have participated, and are participating, in clinical research, I thank you for helping to evolve treatment for yourselves and countless others.