About The Position

The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. This position supports clinical research and requires clinical training requirements to be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. Employment is contingent upon completion of required training, credentialing, and background verification, including clinical research orientation and training (such as CITI and HIPAA), system training, and AHA BLS certification as applicable to job duties. Employees whose responsibilities require access to EHC facilities must also complete a health assessment, drug screening, immunization requirements including annual flu vaccination, competency validation, and other EHC requirements; ongoing compliance is required for continued employment. Position tasks must be performed in person at an Emory University location; remote work is not an option. Emory reserves the right to change this status with notice.

Requirements

  • 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.
  • Completion of 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.
  • For employees whose responsibilities require access to EHC facilities: completion of a health assessment, drug screening, immunization requirements including annual flu vaccination, competency validation, and other EHC requirements, with ongoing compliance.

Responsibilities

  • Manage research project databases, develop flow sheets and other study-related documents, and complete source documents and case report forms.
  • Provide guidance to less experienced staff.
  • Interface with research participants, determine eligibility, and consent 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 of study specimens and their processing.
  • Establish case packages for study procedures, monitor scheduling of procedures 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, perform phlebotomy or diagnostics.
  • Perform related approved responsibilities as required.
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