Emory

  • (Regulatory and Project Coordinator) Clinical Research Coordinator III

    Job Number
    17965
    Job Type
    Regular Full-Time
    Division
    School Of Medicine
    Department
    SOM: HMO: BMT
    This position may involve the following Health and Safety issues:
    Not Applicable
    Job Category
    Research & Research Administration
  • Description

    Exciting and unique vacancy at Emory University! Our ideal candidate will have a clinical research and regulatory background that will aide them in overseeing the start up of multiple clinical trials. In this role you will independently manage significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects.

     

    SPECIFIC JOB DETAILS:

    • Responsible for study start-up, interfacing with study monitors, coordination of site selection visits as well as SIV’s.  Works closely with team PI’s to facilitate opening of new studies. 
    • Collaborates with regulatory staff, OCR, contract and others to facilitate approval of clinical trials and facilitate team needs.
    • Requires strong communication and negotiation skills to competently navigate the steps to move project forward.
    • Provides audit support to team supervisor for team studies
    • Patient contact is limited but understanding of CRC role is critical to success in role.

     

    Trains and provides guidance to less experienced staff. Oversees data management for research projects. Interfaces with research participants and resolves issues related to study protocols. Authorizes purchases for supplies and equipment maintenance. Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.

     

    Monitors IRB submissions and responds to requests and questions. Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. Provides leadership in determining, recommending, and implementing improvements to policies/processes. Assists in developing grant proposals and protocols. With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics. May perform some supervisory duties. Performs related approved responsibilities as required.

     

    PREFERRED QUALIFICATIONS:

    Regulatory experience as well as project coordinator experience preferred. 


    MINIMUM QUALIFICATIONS:

    (1.) High School Diploma or GED and seven years of clinical research experience OR

    (2.) Two years of college in a scientific, health related or business administration program and five years of clinical research experience OR

    (3.) Licensed as a Practical Nurse (LPN) and four years of clinical research experience OR

    (4.) Bachelor's degree in a scientific, health related or business administration program and three years clinical research experience OR

    (5.) Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience

     

    Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.

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