Clinical Research Specialist - Leading Protocol Development Exp. Req. (Job 1416)

Overview

DLH is seeking a Clinical Trials Specialist to join the Network Coordinating Center (NCC) of the ACTG (Advancing Clinical Therapeutics Globally for HIV and Other Infections) network, one of the world's largest and longest-running clinical trials networks focused on HIV and its comorbidities. This clinical trials network conducts dozens of protocols at sites in the US and abroad and is led by some of the world’s leading experts in infectious disease and HIV/AIDS. The Clinical Trials Specialist will be responsible for managing protocol teams as they design, implement, and report results from clinical trials.

Responsibilities

• Leads protocol development, study start-up, and study conduct activities
• Leads development of the protocol document, including incorporating input from subject matter experts and investigators, and developing the informed consent form(s)
• Develops and manages study-specific ancillary documents (e.g., manuals of procedure, site training materials)
• Manages and communicates the status of study progress and activities
• Drives the resolution of issues encountered with sites during all phases of the study
• Partners with cross-functional teams (e.g., clinical data management, statisticians, laboratory) during protocol development and implementation