Research Compliance Coordinator

Lurie Children’s Hospital is committed to providing exceptional healthcare while fostering a diverse and inclusive environment. We prioritize the ethical conduct of clinical research and ensure compliance with all federal, state, and local regulations. We believe that diverse perspectives and experiences strengthen our workplace, and we are dedicated to creating a collaborative and supportive atmosphere for all employees.

Essential Job Functions:

• Regulatory Review & Compliance:
  Provide guidance to investigators and research staff to facilitate the ethical conduct of research by answering questions regarding submission preparation and requirements. Conduct regulatory reviews of research protocol submissions to ensure compliance with federal, state, and local regulations.

• Submission Management:
  Manage all types of submissions, including new studies, amendments, renewals, and incidents. Substantively interpret applicable federal and state regulations for each submission, conducting in-depth pre-reviews.

• Committee Participation:
  Participate in research compliance board meetings (IRB, IBC), prepare agendas, record minutes, document votes, and provide written reports summarizing findings for review and approval by committee chairs.

• Risk and Regulatory Determinations:
  Determine appropriate risk categories and make regulatory determinations (e.g., exempt, expedited, IDE/IND) before forwarding to committees/chairs.

• Feedback and Guidance:
  Provide feedback to investigators and coordinators, guiding them on making necessary modifications to submissions to meet regulations and obtain approval.

• Compliance Program Development:
  Assist in the development and maintenance of compliance programs, including policies, educational/training materials, and forms. Ensure that changes in regulations are reflected in draft policies.

• Tracking & Reporting:
  Track and monitor submissions using a database and provide regular reports to the Director and Chairs. Participate in compliance audits and post-approval monitoring.

• Special Projects:
  Contribute to website development, quality assurance initiatives, and other special projects as needed.

• Continual Learning:
  Participate in internal/external educational events to increase knowledge in research compliance.

• File Management:
  Maintain office files in accordance with regulatory guidelines (e.g., OHRP, FDA).

Knowledge, Skills & Abilities:

• Education:
  Bachelor’s Degree with at least 1 year of relevant experience, or 6 years of experience in lieu of a higher education degree.

• Communication:
  Strong written and verbal communication skills with the ability to communicate with various levels of faculty and staff. Must be able to explain complex regulatory requirements in an accurate, helpful, and customer-service-oriented manner.

• Decision Making:
  Ability to make independent decisions and function autonomously with minimal supervision. Must demonstrate a high level of discretion and confidentiality.

• Regulatory Knowledge:
  Must possess current knowledge of federal, state, and local regulations pertaining to the conduct of research (e.g., DHHS, OHRP, FDA).

• Technical Skills:
  Proficiency with Microsoft Windows applications (Excel, Word, Access) and the ability to navigate web-based systems.

• Professional Development:
  Maintenance of membership in a related professional organization, such as PRIM&R, is expected. Attending conferences and educational events is encouraged.

Education:

• Required: Bachelor’s Degree
• Preferred: 1 year of relevant experience or 6 years of experience in lieu of a degree.

Benefits:

• Medical, dental, and vision insurance
• Employer-paid life and disability insurance
• Health Savings Account contributions
• Paid Time Off (PTO), Paid Holidays, and Paid Parental Leave
• 403(b) with 5% employer match
• Tuition assistance and student loan support
• Adoption benefits and Backup Childcare/Eldercare
• Employee Assistance Program (EAP)
• Discount on services at Lurie Children’s facilities