This spring and summer, I am completing an eight-month co-op with the clinical

monitoring department at Medpace, a Cincinnati-based clinical research organization. As a

clinical research organization, Medpace manages clinical trials to collect data for FDA review
and potential approval of new medical therapies on behalf of pharmaceutical companies,
biotechnology companies, and medical device companies. The clinical monitoring department is
responsible for maintaining the safety of patients participating in the clinical trials and validity of
the data reported by research sites. The opportunity has been rewarding because it has shown me
a potential career path in academic medicine besides basic scientific lab research. Lab research
often felt far removed from an eventual new treatment or cure for a disease and dictated more by
what topics would win grant money than what principal investigators really wanted to study. The
clinical research at Medpace is exciting because it involves data collection for approval of drugs
and devices ready to treat sick people. The studies enroll many people who have had limited
success with other therapies and are being given a new option and hope. My previous co-ops
focused on lab research and exposed me to only a little clinical research. My principal
investigator screened mothers of children with congenital heart disease as a supplement to his lab
research and I remember another doctor he worked with briefly discussing his involvement in
trials to collect data for a novel pulmonary valve prosthetic, but those were my only exposures to
clinical research. I thought that the primary way for physician-scientists to contribute to the
research and development of new therapies to the diseases they treat was lab research. I did not
realize until I started working at Medpace that there are hundreds of thousands of clinical
research sites run by physicians across the world, many at academic hospitals. I also did not
realize the opportunity for physicians to work at companies like Medpace as therapeutic area
experts and subject safety monitors during clinical trials.
Luckily, I am only halfway through my co-op at Medpace, so I will have the rest of the
summer to continue learning about clinical research. I am attending clinical trial management
training and I recently completed training to help the data management group lock a database.
This is an entirely new responsibility for me within a new functional area, so I am excited to
learn more and contribute to a final database for a client. Both of these job roles are responsible
for subject safety and data validity. Data validity is important to maintaining safety of the un-
monitored general population taking a drug once it receives marketing approval. If adverse
events are not reported or if data is manipulated, people can be endangered. When I return to
classes in the fall, I will be completing a capstone that will involve pre-clinical research on a
prosthetic tricuspid valve. The valve is designed to grow with young patients, eliminating the
need for recurrent surgeries but it must be proven no more dangerous than currently available
therapies in an animal model before human testing can begin. This will give me full exposure to
most of the steps of new therapy development including initial benchtop research, preclinical
research, and FDA drug/device approval studies. I am excited about the work I will be doing in
the next year as it contributes to meeting unmet needs in medicine. I hope to continue working in
clinical medicine and clinical research after I graduate.