About The Position

The Clinical Research Coordinator II supports clinical research at the Hope Clinic of the Emory Vaccine Center, an international Center of Excellence conducting clinical and translational research on infectious disease vaccines, treatment, and prevention. The clinic conducts human research studies and clinical trials involving vaccines, treatments, prevention, community-based research, and laboratory-based translational human immunology. The coordinator handles administrative activities associated with clinical trials, including managing study information and documentation, supporting participant recruitment and enrollment, coordinating study procedures and services, overseeing specimen collection and processing, and ensuring protocol compliance. The position may also involve phlebotomy or diagnostics when the employee has the appropriate credentialing and training. The role may work from home regularly, but requires commuting to Emory University on a flexible weekly schedule based on business needs and department guidelines. The employee must reside in Georgia. Emory may change the remote-work status with notice. Clinical training requirements must be tracked and monitored through Emory Healthcare under the Clinical Researcher credentialing category.

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 practical nurse licensure (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.
  • Clinical training requirements must be tracked and monitored through Emory Healthcare under the Clinical Researcher credentialing category.
  • Must reside in Georgia.
  • Must be able to commute to Emory University on a flexible weekly schedule based on business needs.

Responsibilities

  • Manages research project databases, develops flow sheets and other study-related documents, and completes source documents and case report forms.
  • Provides guidance to less experienced staff.
  • Interfaces with research participants, determines eligibility, and obtains informed consent according to protocol.
  • Approves orders for supplies and equipment maintenance.
  • Assists in developing recruitment strategies and conducts participant screenings, including interviews and questionnaires.
  • Supervises collection and processing of study specimens.
  • Establishes case packages for study procedures, monitors procedure scheduling and charges, and coordinates other services as needed.
  • Ensures compliance with research protocols, reviews case report forms, audits them for accuracy against source documents, and attends sponsor monitoring meetings.
  • Prepares regulatory submissions.
  • May perform phlebotomy or diagnostics with appropriate credentialing and training.
  • Performs related approved responsibilities as required.
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