Clinical Research Coordinator II- Winship Cancer Institute

Emory•Atlanta, GA

17h

About The Position

The Clinical Research Coordinator II at Winship Cancer Institute of Emory University handles administrative activities generally associated with conducting clinical trials and provides guidance to less experienced staff. The role supports clinical research and requires completion and ongoing monitoring of applicable clinical training, credentialing, health, and employment requirements. The coordinator manages research project databases and study documentation; interacts with research participants to determine eligibility and obtain protocol-based consent; supports participant recruitment and screening; and coordinates study procedures, specimens, services, and charges. The role also helps ensure protocol compliance, reviews study records for accuracy, attends sponsor monitoring meetings, and prepares regulatory submissions. With appropriate credentialing and training, the coordinator may perform phlebotomy or diagnostics.

Requirements

High school diploma or GED and five years of clinical research experience; or two years of college in a scientific, health-related, or business administration program and three years of clinical research experience; or licensure as a practical nurse (LPN) and two years of clinical research experience; or a bachelor's degree in a scientific, health-related, or business administration-related program and one year of clinical research experience; or a master's degree, MD, or PhD in a scientific, health-related, or business administration program.
Complete all required training, credentialing, and background verification, including clinical research orientation and training (e.g., CITI and HIPAA), system training, and AHA BLS certification as applicable to job duties.
If responsibilities require access to EHC facilities, complete a health assessment, drug screening, immunization requirements including annual flu vaccine, competency validation, and any other EHC requirements; maintain ongoing compliance for continued employment.

Responsibilities

Manage research project databases, develop flow sheets and other study-related documents, and complete source documents and case report forms.
Interface with research participants, determine eligibility, and consent study participants according to protocol.
Approve orders for supplies and equipment maintenance.
Assist in developing recruitment strategies and conduct participant screenings, including interviews and questionnaires.
Supervise collection and processing of study specimens.
Establish case packages for study procedures; monitor procedure scheduling and charges; and coordinate other services as needed.
Ensure compliance with research protocols, review case report forms, and audit them for accuracy against source documents.
Attend sponsor monitoring meetings.
Prepare regulatory submissions.
With appropriate credentialing and training, perform phlebotomy or diagnostics.
Provide guidance to less experienced staff.
Perform related approved responsibilities as required.