- University of Colorado (Aurora, CO)
- IND / IDE Office Program Manager - 34555 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Clinical ... Research and Operations Services** **Job Title: IND / IDE Office Program Manager** **Position #: 797456 - Requisition #: 34555** **Job Summary:** Key… more
- Johns Hopkins University (Baltimore, MD)
- …investigator held INDs and IDEs in accordance with the JHU governing guideline. The IND / IDE Program Director will develop and maintain all operational ... functions that support IND / IDE activities in the Office ...Title: Sr. Policy Associate Job Posting Title (Working Title): IND / IDE Program Director Role/Level/Range: ATP/04/PF… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and education regarding regulatory requirements, review of FDA submissions for investigator-held IND or IDE research, and review of select protocol and ... regulatory filings to the FDA (primarily Investigational New Drug ( IND ) and Investigational Device Exemption ( IDE ) applications). Activities… more
- 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 ... of Food and Drug Administration ( FDA ) requirements, Office of Human Research Protection ( OHRP ), International...rules and regulations, including complex protocol, multi-site trial and IND / IDE issues. 8. Offers mentorship… more
- Guidehouse (Bethesda, MD)
- …amendments, audits, and other administrative documentation. + Develop new and review completed IND and IDE safety, clinical study reports and other regulatory ... navigation and regulatory writing for the NINDS Intramural Research Program . + Coordinate with other offices eg, Office...staff, and safety, regulatory, and monitoring entities. + Prepare IND and IDE safety, clinical study reports… more
- University of Pennsylvania (Philadelphia, PA)
- …design, set-up and execute studies. Be responsible for writing investigator-initiated IND / IDE clinical trials in collaboration with faculty supervisor. Speak ... and various sponsors. This position will report directly to the Airways Program Manager and work directly with Physician Investigators ("PI") on clinical research… more
- University of Pennsylvania (Philadelphia, PA)
- …managing different quality aspects of cell manufacturing, participate in drafting IND / IDE Chemistry, Manufacturing and Controls (CMC) sections, including ... clinical trials under Investigational New Drug or Device Exemptions ( IND /IDEs) approved by the FDA, some of which are...available. The candidate is encouraged to tailor the one-year program to suit individual background and needs, while still… more
- University of Pennsylvania (Philadelphia, PA)
- …design, set-up and execute studies. Be responsible for writing investigator initiated IND / IDE clinical trials in collaboration with faculty supervisor. Speak at ... as directed by the ACC CRU Myeloma Research Team Program Manager. + Be actively involved in planning and...to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening… more
- Johns Hopkins University (Baltimore, MD)
- …process. + Consult and advise teams regarding preparation and maintenance of IND / IDE and other regulatory documentation for external agencies, which are ... Clinical and Translational Science Awards (CTSA) facilitate their Trial Advisory Program (TAP) focusing on the development of investigative expertise, such as,… more