I have been working as a PA and Clinical Investigator at DaVita Clinical Research in Minneapolis for over three years.  DaVita Clinical Research is a Phase I-IV clinical trial site specializing in renal trials.  We perform approximately 40 Phase I and II renal trials, and five large normal healthy volunteer research trials yearly at our site, which is similar to an inpatient unit.  Our capabilities include Phase I-IV, including first-time-in-human, pharmacokinetics, pharmacodynamics, mass balance, GFR, radiolabeled, and other specialty research studies.  Our volunteer population ranges from normal healthy volunteers to pre-ESRD and ESRD patients.  DaVita has worked with over seventy-five drug and device companies in their 15 years, ranging from “Big Pharma” to smaller pharmaceutical companies.

My main role in our research unit, in conjunction with my supervising physician, is clinical and medical oversight of volunteers enrolled in our research trials.  The job of a Clinical Investigator requires an advanced practice degree or medical degree, as it is imperative to have the medical training in order to perform the necessary tasks of a Clinical Investigator.  I am also a Certified Clinical Trials Investigator (CCTI) which is a formal recognition of non-physician Investigators who have met the professional eligibility requirements and demonstrated job-related knowledge and skills regarding clinical research, GCP/ICH guidelines, and FDA regulations.

I head into work each weekday at 0700, and open up my laptop to check my schedule and e-mails.  I receive about fifty emails daily from the study staff, and study sponsors.  I head out to the nurses’ station, and sign off on screening and follow-up laboratory reports.  Specifically, it is my responsibility to decide whether an abnormal lab is clinically significant or not, and if so, how to proceed.  The first volunteers arrive for screening any coordinators, recruiters, nursing stime after 0700.  It is my responsibility as a Clinical Investigator to make sure each protocol is followed precisely.  Each volunteer must be consented to participate in a research trial, and this involves an extensive discussion among the volunteers, research nurses, and myself.  It is extremely important that the volunteers understand their rights, responsibilities as a research participant, and the nature of and potential side effects of the study drug.  All of the volunteers’ questions are answered and there is ample time for discussion prior to the volunteer signing consent.

The research staff completes the initial screening of the subject, and then it is my turn to review the Informed Consent with each volunteer, and perform a thorough medical history and physical examination, in order to determine if there are any underlying conditions that would preclude the volunteer from participating in the particular study.  In a normal healthy volunteer, this part is typically fairly straightforward.  However, in one of our ESRD patients, it can be a bit more complicated.

Dosing days are the busiest of days.  We may have anywhere from one to fifteen or more volunteers dosing with a study drug on any given weekday.  Some of the trials involve a single dose of study drug in a double-blinded fashion, and others require multiple dosings.  Drug administration can be oral, intravenous, inhaled, or transdermal.  The volunteers are monitored extremely closely for any changes in his or her health, which then are deemed “adverse events,” which I assess.  Most importantly, I determine whether or not it is likely that it is related to the study drug, and how to treat, if applicable.  This is part of the process to determine side effect profiles of drugs. 

The office-based part of my job involves reviewing new protocols, writing study protocols for sponsors, addressing questions and concerns of monitors from various companies, and assisting with management of clinical staff.  I also meet almost daily with study coordinators and the other managerial staff to discuss ongoing trials, enrollment needs, recruitment ideas, and any other issues. 

It is 1600, and I am usually wrapping things up by now.  I reflect on my day, and realize that it is truly exciting to be able to work in this field of clinical research, one where we are working diligently many years before the release of a new drug to help ensure it is safe and effective.  I hope that my work here will one day lead to a positive difference in patients’ lives.