- University of Utah (Salt Lake City, UT)
- …and report forms. 2. Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports. 3. Analyzes and mitigates ... rules and regulations, including complex protocol, multi-site trial and IND / IDE issues. 8. Offers mentorship...discriminate on the basis of sex in the education program or activity that it operates, as required by… more
- University of Miami (Miami, FL)
- …Compile regulatory-related metrics for use by senior management. Preparation and submittal of IND and/or IDE applications and annual reports to the FDA for ... Analyst 3 - UHealth assists the Regulatory Manager and/or Director of Regulatory with the day-to-day operations related to...the development and improvement of the + department's mentorship program . + Assists with the training of all regulatory… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …data management, and coordination of investigational product. IDE / IND submission experience preferred. **Education/Licensure/Certification:** Bachelor's ... center, with guidance from the appointed consortium leaders (eg, Consortium Medical Director , Associate Medical Director , Administrative Director , etc.). The… more
- University of Miami (Miami, FL)
- …submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation. + Coordinates the efforts of relevant team ... quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual reports for delegated… more
- University of Miami (Miami, FL)
- …submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation. + Coordinates the efforts of relevant team ... quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual reports for delegated… more