- 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
- National Institutes of Health (Montgomery County, MD)
- …in providing regulatory guidance, safety oversight, operational support, and inspections to ensure IND and IDE products are developed by the CCR in compliance ... Summary This position is located in the Office of Sponsor and Regulatory Oversight (OSRO), ...regulatory staff; reviewing and submitting Investigational New Drug Applications ( IND ) and Investigational Device Exemptions ( IDE ) to… 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
- Children's Hospital Boston (Boston, MA)
- …in the preparation, submission and maintenance of Investigational New Drug ( IND ) and Investigational Device Exceptions ( IDE ) applications. + Serve ... applicable regulatory requirements, including responsibilities of sponsor-investigators related to IND / IDE , ClinicalTrials.gov registration and reporting requirements. +… 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 ... products and various sponsors. This position will report directly to the 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
- University of Pennsylvania (Philadelphia, PA)
- …submissions and data entry). + May be responsible for writing investigator-initiated IND / IDE clinical trials in collaboration with faculty supervisor. Speak at ... Research Project Manager A Job Description Summary The Pennsylvania Hospital Research Program of the University of Pennsylvania seeks a full-time Sr. Clinical… 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
- University of Pennsylvania (Philadelphia, PA)
- …and execute studies. Be responsible for helping to write/review investigator initiated IND / IDE clinical trials in collaboration with faculty supervisor. Speak at ... B: This individual will work under general supervision. Assist CTT program manager with initiating study procedures for new industry-sponsored and… more
- Dartmouth Health (Lebanon, NH)
- …manages complex research studies and programs. Experience working on investigator intiated IND 's/ IDE 's a plus. * Reviews sponsored research applications and ... as letters and brochures. * Works with the SPA office and Principle Investigators to ensure completion of required...staff and trainees in both clinical trials and sponsored program areas * Designs, establishes, and provides training programs… more