ANDREA LUDWIG
Fargo
Summary
Dynamic IRB Administrator with a proven track record at North Dakota State University, excelling in regulatory compliance and strategic communication. Achieved a 30% reduction in protocol turnaround time while enhancing quality assurance. Expert in risk assessment and project management, driving institutional accountability and fostering collaboration across diverse teams.
Overview
13
13
years of professional experience
Work History
IRB Administrator
North Dakota State University
Fargo
08.2023 - Current
- Provide executive oversight of institutional compliance with 45 CFR 46 (Common Rule), 21 CFR 50 & 56 (FDA), ICH-GCP, and HIPAA, ensuring enterprise-wide adherence to human subjects protections.
- Led institutional preparedness for FDA, OHRP, and AAHRPP accreditation reviews, directing audit responses and corrective action plans to ensure compliance.
- Develop and implement IRB policies, Standard Operating Procedures (SOPs), and governance frameworks aligned with federal, state, and institutional requirements.
- Oversee comprehensive risk assessments of research protocols to safeguard human subjects and ensure ethical and regulatory integrity.
- Direct post-approval monitoring and quality assurance programs to mitigate compliance risk and strengthen institutional accountability.
- Provide strategic leadership for IRB operations managing 600+ research protocols annually, maintaining 100% regulatory compliance.
- Optimized IRB review workflows, reducing average protocol turnaround time by 30% while preserving regulatory rigor.
- Serve as institutional subject matter expert and senior advisor to executive leadership, legal counsel, compliance officers, and investigators on complex regulatory and ethical matters.
- Designed and oversaw comprehensive IRB education programs for faculty, investigators, and research staff, resulting in 40% improvement in submission quality.
Graduate Medical Education Program Manager
Sanford Health
Fargo
02.2020 - 08.2023
- Led the accreditation application process to full approval with zero deficiencies.
- Directed operational, financial, and accreditation functions for a complex fellowship program, ensuring full compliance with ACGME and institutional requirements.
- Developed and implemented supplemental curriculum and professional development initiatives, enhancing fellows' and faculty's competencies.
- Strengthened collaboration among faculty, administrators, and national partners, advancing program goals and enhancing institutional visibility.
- Prepared and produced high‑level reports, evaluations, and strategic documentation, informing decision-making for executive and clinical leadership.
- Supported research initiatives by advising fellows on study design, implementation, and reporting.
Supervisor of Operations, Provider Enrollment
Noridian Healthcare Solutions
Fargo
06.2013 - 02.2020
- Oversaw daily operations for large team managing provider enrollment and ensuring compliance with federal standards.
- Established performance expectations, monitored productivity, and coached staff to achieve operational goals.
- Managed budgets, audits, and process‑improvement initiatives to streamline workflows and increase accuracy.
- Facilitated communication across teams to uphold compliance and enhance customer service quality.
- Partnered with executive leadership on contract development, service expansion, and organizational growth initiatives.
- Led planning and execution of a national provider conference with 1,000+ attendees, elevating organizational visibility and stakeholder engagement.
Education
Master of Science (M.S.) - Public Health
North Dakota State University
Fargo, ND05.2026
Master of Business Administration (M.B.A.) - Health Care Management
Capella University
Minneapolis, MN11.2019
Bachelor of Science (B.S.) - Sociology
Minnesota State University Moorhead
Moorhead, ND11.2009
Skills
- Regulatory compliance
- Risk assessment
- Quality assurance
- Data analysis
- Project management
- Stakeholder engagement
- Strategic communication
- MS office
- Goal setting
References
References available upon request.
Timeline
IRB Administrator
North Dakota State University
08.2023 - Current
Graduate Medical Education Program Manager
Sanford Health
02.2020 - 08.2023
Supervisor of Operations, Provider Enrollment
Noridian Healthcare Solutions
06.2013 - 02.2020
Master of Science (M.S.) - Public Health
North Dakota State University
Master of Business Administration (M.B.A.) - Health Care Management
Capella University
Bachelor of Science (B.S.) - Sociology
Minnesota State University Moorhead