**PURPOSE AND SCOPE:**

Provides administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the

Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of

regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and

governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity.

**PRINCIPAL DUTIES AND RESPONSIBILITIES:**

+ Assists with obtaining and preparing regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms.
+ Under close supervision, ensures documents and forms are compiled and submitted in a timely manner to the CRO, study sponsor or IRB as applicable.
+ As...