JulieAnn Blasingim
VP, Compliance and Development
Elligo Direct
Julie Blasingim has over 18 years of regulatory, operational, and compliance experience in the human research protection field and currently serves as Vice President of Compliance & Development at Elligo Health Research.
At Elligo, Blasingim is a highly valuable member of the leadership team. She specializes in overseeing corporate wide quality and training management systems. Blasingim vetted, selected, implemented and led the development of the current eQMS system. Blasingim is responsible for setting company quality objectives and standards, designing policies, procedures and systems that establish compliance. This includes coordinating with Security and Privacy Officers to develop information and privacy management systems. Given Blasingim’s extensive work history she is also responsible for overseeing the corporate regulatory Intelligence Team, all FDA Inspections, Customer Audits, Company Quality Audits and Qualification Assessments. Blasingim drives efficiency in company-controlled document management, CAPAs and training for all internal staff and external Investigators.
Before Elligo, Blasingim served as the VP, Corporate Quality Assurance, Process Improvement, and Training for Advarra. Blasingim is uniquely experienced to have a broad understanding of the entire IRB business, having served in several roles responsible for providing leadership and oversight within the organization, ensuring compliance with policies and regulatory requirements, and providing timely and quality review services to clients.
Before Advarra, Blasingim played a key role in the development and expansion of several service lines at Schulman IRB, including clinical pharmacology/Phase I, institutional review and support, Central Oncology Review (COR) IRB panel, and eConsent. She has also served as IRB chair and led and organized the application process for AAHRPP accreditation, FDA audits, ISO certifications, project management, change management, process improvement, and other strategic initiatives. Blasingim has also served as a key member of investor meetings and integration teams for six IRB-related mergers and acquisitions.
Blasingim holds a bachelor’s degree in education and a master’s degree in business administration specializing in leadership and has maintained her Certified IRB Professional (CIP) certificate for 10 years. She provides training and educational sessions within the company, to researchers, and for professional learning groups and conferences across the research community and has also authored two training modules offered by CITI.