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Coor Research RN

Wellstar Shared Services • Marietta, GA • Nursing: Non-Bedside • 105187 • Days • Full-Time


The Research Coordinator has general responsibility for managing clinical trials for the Clinical Trials Office of the WellStar Health System. This includes responsibility for identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating therapy initiation and continuation; taking call for issues related to clinical trials; completing and filing necessary forms with internal and external departments and agencies as necessary; and maintaining records for patients enrolled in clinical trials.


Core Responsibilites and Essential Functions

  • Coordinates all facets of patient involvement in clinical trials.
    * Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
    * Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines.
    * Communicates with physician/office staff regarding scheduling protocol specific requirements.
    * Attends patient visits and gathers protocol-specific information when required.
    * Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate.
    * Coordinates dispersement of protocol provided drug therapy.
    * Ensures that Investigation Product chain-of-custody practices are instituted and documented.
  • Maintains accurate records for patients enrolled on clinical trials.
    * Communicates effectively with Research Assistants and other research staff.
    * Gathers appropriate source documentation
    * Submits required documentation within designated time frame.
    * Provides proper documentation of eligibility, treatment and follow-up requirements.
    * Provides accurate research information to physicians and sponsors.
    * Maintains a current chart on each protocol patient.
    * Enters patient visits into clinical trial database.
  • Ensures regulatory guidelines are followed.
    * Prepares research charts for monitoring visits and audits and assists with visits as required.
    * Follows guidelines and timelines for reporting Adverse Events and Deviations.

    * Maintains current protocol with revisions, amendments and current IRB approved informed consent.
  • Ensures clinical trial and sponsor-required training is completed.
    * Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.
    * Ensures that ongoing training during the course of a clinical trial is completed.
    * Facilitates ongoing training for other team members, including investigators.
    * Maintains current Human Research Participant Protection and Hazardous Material training.
  • Assists with other departmental functions.
    * Attends committee meetings as required.
    * Attends functional team meetings and disseminates information.
    * Assists with regulatory and billing functions, when required.
    * Responsible for additional projects, as directed by the manager.

  • Required for All Jobs

  • Performs other duties as assigned
  • Complies with all WellStar Health System policies, standards of work, and code of conduct.

  • Qualifications

    Required Minimum Education

  • Graduate from an approved school of nursing. Required and
  • Bachelor's Degree BSN Preferred

  • Required Minimum Experience

  • Minimum 5 years of experience as a nurse; Required and
  • Hospital experience Preferred and
  • Critical Care experience Preferred and
  • Research experience Preferred

  • Required Minimum Skills

  • Strong computer skills;
  • good oral and written communication skills;
  • excellent interpersonal and organization skills.

  • Required Minimum License(s) and Certification(s)

  • Reg Nurse (Single State) 1.00 Required 1.00
  • RN - Multi-state Compact 1.00 Required 1.00

  • Additional Licenses and Certifications

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