Comalita Lee, MPH, BAAS, CRP, AHP

The Senior Clinical Research Lead is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator, the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The Sr. CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies. The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities. The Sr. CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.

Decentralized Research Service and Operations Management.

•Clinical Research Manager, IRB specialist, Quality Control Manager, Site Monitor, Research Educator for the Division of Urology. Regulatory and compliance manager. .Design, execute and interpret results of complex experiments. Conduct complex scientific experiments and research endeavors. •Ensure all studies meet governmental and university policy and protocol compliance. •Recruitment and enrollment of human subjects and maintain accurate and confidential records and databases. •Data collection, analysis, or monitoring; case management of protocol participants; protection of subjects and subjects’ rights through IRB relations; development of informed consent documents; preparation of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records; preparation of reports; educating other healthcare professionals, patients or families about clinical trials, protocol development, and program administration; and auditing research programs. •Make independent decisions as required, which may impact research team or assigned project. •Provides outpatient clinical care for all participants in department clinical trials.