Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects. Trains and provides guidance to less experienced staff. Oversees data management for research projects. Interfaces with research participants and resolves issues related to study protocols. Authorizes purchases for supplies and equipment maintenance. Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.
Monitors IRB submissions and responds to requests and questions. Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. Provides leadership in determining, recommending, and implementing improvements to policies/processes. Assists in developing grant proposals and protocols. With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics. May perform some supervisory duties. Performs related approved responsibilities as required.
(1.) High School Diploma or GED and seven years of clinical research experience OR
(2.) Two years of college in a scientific, health related or business administration program and five years of clinical research experience OR
(3.) Licensed as a Practical Nurse (LPN) and four years of clinical research experience OR
(4.) Bachelor's degree in a scientific, health related or business administration program and three years clinical research experience OR
(5.) Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.