Research Nurse

Develops, implements, and supports research process by assisting investigators in study design, completion of approval process, and management of data specific to subspecialty of involvement. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.

• Graduation from an accredited school of nursing;
  Bachelor of Science in nursing preferred

• Licensure as a Registered Nurse in the single State of Georgia or Multi-State through the Enhanced Nurse Licensure Compact

• ARUP Handling, Packaging and Shipping Infectious Material or similar certification within 30 days of employment (if role requires specimen acquisition)
• Collaborative Institutional Training Initiative (CITI) within 30 days of employment
• Basic Life Support (BLS) within 1 year of employment

• Two or more years of pediactric clinical experience OR four or more years of clinical related experience

• Bachelor of Science in Nursing
• Experience in the subspeciality of involvement
• 1 year of experience in research with knowledge about the conduct of clinical trials, research principles/methodologies, and study design
• Pediatric Advanced Life Support (PALS)

• Working knowledge of federal regulations and regulatory requirements for conducting research
• Good computer skills, including working knowledge of a personal computer and Microsoft Office (Word, Access, Excel, and PowerPoint) and basic statistics
• Must be able to successfully pass the Basic Windows Skill Assessment at 80% or higher rating within 30 days of employment
• Self-directed and motivated to work independently toward short- and long-term goals
• Good communication, organization, and interpersonal skills

1. Develops, conducts, and facilitates research protocols.
   • Supports investigators in writing study protocols.
   • Performs participant screening, enrollment, study activities, and communication.
   • Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
   • Maintains equipment and supply resources for research studies.
   • Obtains informed consent by following Children’s Healthcare of Atlanta policies, procedures, and regulatory requirements.
   • Schedules study-specific visits in conjunction with ancillary departments.
2. Provides direct patient care to conduct research protocols.
   • Provides direct nursing care according to Children’s Healthcare of Atlanta standards of practice.
   • Completes phlebotomy for acquisition of research specimens.
   • Administers research medications under a study-specific protocol.
   • Completes nursing physical assessment, vital signs, and venous access.
   • Completes clinical assessment and safety evaluation of study subjects and notifies Principle Investigator when appropriate.
   • Reviews and grades adverse events, concomitant medications, VS’s, and lab results and notifies Principle Investigator when appropriate.
   • Provides health education to participants as part of a study protocol.
   • Completes nursing documentation and order entry within the medical record.
3. Manages all regulatory processes related to clinical research activities.
   • Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
   • Maintains all regulatory documents.
   • Participates in sponsor correspondence, monitoring, and study meetings.
4. Completes data management activities.
   • Assists in development and completion of source and case report form documentation.
   • Completes data entry and ensures data integrity.
   • Supports statistical services needs.
5. Facilitates grants, contracts, and financial tasks for research and clinical trials.
   • Supports investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
6. Performs quality and education activities.
   • Monitors compliance throughout all study activities.
   • Engages compliance oversight as needed.
   • Participates in education activities to support specific research activities and primary role.
   • Maintains all licensure, certification, and system education requirements for role.
   • Participates in educational activities related to study needs for study staff, investigator team, and patient care staff.
   • Participates in departmental policy and quality projects.

Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.

Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.