Job Summary:
The Clinical Research Associate II (CRA II)will join a team of experienced coordinators and manage various research trials, including first in human through phase 3 trials. The role will be expected to manage 4 or more studies simultaneously. The CRA II will ensure compliance with FDA guidelines and follow GCP for all managed studies. The CRA II will interact daily with clinicians, sponsors, IRB, regulatory agencies and other research professionals. This is a subject / patient facing role, the candidate needs the ability to communicate directly with study volunteers, collecting detailed clinical information and communicating that to the study team. The CRA II will be responsible for all aspects of the trial conduct including; IRB submission, regulatory documents, training staff, overseeing enrollment of appropriate study subjects, creation and completion of source documents, database entry and query resolution. This position will be the point person on assigned clinica...