Director of Research Compliance

Nemours - Wilmington, DE

Full-time - Director

Wilmington, DE

Hospitals

About the position

The Director of Research Compliance at Nemours is responsible for implementing and leading the research compliance program across various research activities, including clinical and translational research. This role involves creating the Office of Research Compliance, providing leadership in compliance matters, conducting risk assessments, and ensuring adherence to federal and state regulations. The Director will also oversee training programs and coordinate with multiple departments to achieve compliance objectives.

Responsibilities

• Implement and lead the Nemours research compliance program for all research activities.
• Create and manage the Office of Research Compliance.
• Conduct investigations and resolve research compliance issues.
• Perform research compliance risk assessments and maintain relevant policies and procedures.
• Provide regulatory guidance on research compliance matters.
• Coordinate training and education on research compliance for staff.
• Develop and oversee policies regarding compliance with federal and state laws related to research funding.
• Implement and direct the export compliance program for Nemours.
• Conduct inquiries and investigations related to research misconduct.
• Serve as a resource on laws and regulations related to research compliance.

Requirements

• Bachelor's Degree required; Master's Degree preferred in health policy, research administration, business administration, or legal/regulatory fields.
• Post Graduate Juris Doctorate degree preferred.
• Valid compliance certifications: Certified in Healthcare Compliance (CHC) and Certified in Healthcare Research Compliance (CHRC).
• Certified in Healthcare Privacy Compliance (CHPC) preferred.
• Minimum 5 years of experience in the research compliance field required; 7+ years preferred.