Research QA/QI Analyst

Children's Healthcare Of Atlanta - Brookhaven, GA

Full-time - Mid Level

Brookhaven, GA

Ambulatory Health Care Services

About the position

The QA/QI Analyst at Children's Healthcare of Atlanta plays a crucial role in ensuring compliance with research protocols and regulations. This position involves auditing and monitoring clinical studies to ensure adherence to research compliance standards. The analyst will proactively support efforts to deliver safe patient care and promote a secure environment within the healthcare setting. The role requires a strong commitment to the mission of making children better today and healthier tomorrow, reflecting the organization's culture of putting people first and prioritizing children's health. In this position, the analyst will provide leadership in compliance for research activities, developing and implementing policies and procedures that align with both internal standards and external regulations. The analyst will also be responsible for guiding staff on federal and state regulations, participating in the review of reportable events, and engaging in quality improvement initiatives to enhance compliance in research practices. Collaboration with the Institutional Review Board and Research Administration leadership is essential to create a yearly compliance plan that identifies trends and addresses noncompliance issues. The QA/QI Analyst will direct monitoring activities, serve as a liaison for external study monitors and auditors, and develop a routine monitoring plan in conjunction with leadership. Reporting on monitoring findings, risk assessments, and recommendations for education and policy changes will be a key responsibility. The analyst will also provide educational resources to research staff and investigators, ensuring that all personnel are well-informed about compliance requirements. Participation in the Operational Compliance Committee and its subcommittees will further enhance the analyst's role in promoting research integrity and compliance within the organization.

Responsibilities

• Audits and monitors clinical studies for research compliance.
• Supports efforts to ensure safe patient care and services.
• Develops and implements research policies and procedures in line with regulations.
• Provides guidance on federal and state regulations and guidelines.
• Participates in the review of reportable events.
• Engages in quality and continuous improvement activities for compliance.
• Works with the Institutional Review Board to develop a yearly compliance plan.
• Directs and completes monitoring activities for research compliance.
• Serves as a liaison for external study monitors and auditors.
• Develops and oversees a yearly routine monitoring plan.
• Provides reports on monitoring findings and risk assessments to leadership.
• Educates research staff and investigators on compliance requirements.
• Participates in the Operational Compliance Committee.

Requirements

• Bachelor's degree in a scientific, health-related, or business administration program.
• Three years of experience in facilitating or managing clinical research or compliance.
• Knowledge of regulatory requirements related to pediatric clinical research.
• Ability to communicate effectively with technical and non-technical personnel.
• Experience with indexing, cataloging, referencing, and archiving information.
• Demonstrated ability to interpret complex information and develop operational policies.
• Experience in information systems and familiarity with Microsoft Office.

Nice-to-haves

• Graduate degree in a relevant field.
• Pediatric experience in clinical research.

Benefits

• Health insurance coverage.
• Paid holidays and vacation time.
• Professional development opportunities.
• Flexible scheduling options.
• Employee discount programs.