Clinical Research Coordinator II- Winship Cancer Institute

Emory University•Atlanta, GA

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 position supports clinical research and requires tracking and monitoring all clinical training requirements. Employment is contingent on completing required training, credentialing, and background verification. Requirements may include clinical research orientation and training (such as CITI and HIPAA), system training, and AHA BLS certification as applicable to job duties. Employees who need access to EHC facilities must also meet applicable health assessment, drug screening, immunization (including annual flu vaccine), competency validation, and other EHC requirements, with continued compliance required for employment.

Requirements

Meet one of the following qualification pathways: High school diploma or GED and five years of clinical research experience; two years of college in a scientific, health-related, or business administration program and three years of clinical research experience; practical nurse (LPN) licensure and two years of clinical research experience; 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 required training, credentialing, and background verification, including clinical research orientation and training (e.g., CITI and HIPAA) and system training.
Obtain AHA BLS certification as applicable to job duties.
If responsibilities require access to EHC facilities, complete applicable health assessment, drug screening, immunization requirements including annual flu vaccine, competency validation, and other EHC requirements; maintain ongoing compliance.

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 obtain informed consent according to protocol.
Approve orders for supplies and equipment maintenance.
Assist in developing recruitment strategies and conduct participant screenings, including interviews and questionnaires.
Supervise the 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, audit them for accuracy against source documents, and attend sponsor monitoring meetings.
Prepare regulatory submissions with appropriate credentialing and training.
May perform phlebotomy or diagnostics.
Perform related approved responsibilities as required.
Provide guidance to less experienced staff.
Track and monitor clinical training requirements.