IND/IDE Specialist
Jonna has over 23 years of experience working with the FDA, beginning in regulatory compliance in drug development at a biotech company and then moving over to academic clinical research in 2003. She has been in the role of IND/IDE Specialist at the University of Utah since 2016. Jonna has extensive experience developing, coordinating, and implementing research strategies essential to the successful management of FDA meetings, Investigational New Drug (IND) applications for preliminary studies, Phase I, II, III, and/or IV clinical trials and Investigational Device Exemptions (IDE). She offers high-level expertise, guidance, and support to investigators by reviewing, developing, and submitting applications to the FDA to support sponsor-investigator INDs and IDEs, and managing active IND and IDEs and IND/IDE closures. Outside of work, Jonna enjoys time with her family, the outdoors, camping, and exploring.
What Our IND/IDE Specialist Can Do For You
- Compile essential documents such as initial and amended protocols and consent documents, investigational drug or device information, and FDA required documents and forms
- Review essential documents required for FDA regulated study submissions
- Review FDA IND and IDE applications prior to submission
- Serve as a primary point of contact with the FDA
- Develop IND/IDE related policies, procedures, and templates
- Develop and report on program performance metrics
- Maintain master IND and IDE files
- Assist with internal and external QA audits
- Participate in required IND/IDE meetings and workshops
PHONE: (307) 709-0119