Edye Edens,JD, MA, CIP, CCRP
Research Compliance
Edye Edens is a licensed attorney with a background in international human rights, research ethics, and health law. She completed her MA in International Research Ethics in 2012, she worked the program manager for an NIH grant for international institutional review boards partnering in Kenya, she is a Certified IRB Professional (CIP,) Certified Clinical Research Professional (CCRP), and she holds a green belt certification in lean six sigma. Ms. Edens also teaches at Indiana Univerity’s McKinney School of Law and oversees the Hall Center for Law and Health Externship Program.
Her consulting services include research administration, healthcare compliance, grants/contracts to IRB(s), COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology. Services provided include education and training, program creation and management, and/or complete outsourcing solutions. Ms. Edens also publishes and speaks regularly at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA.
Edye has agreed to bring her experience to CRPN’s board of advisors as an industry expert in research compliance and regulatory operations.