- University of Pennsylvania (Philadelphia, PA)
- …with minimal supervision, prepare and process all regulatory documentation through the IRB , CTSRMC, FDA and all applicable regulatory review committees- ... participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist -CC is expected… more
- University of Pennsylvania (Philadelphia, PA)
- …regulatory documentation through the IRB , FDA and all applicable institutional regulatory review committees. In collaboration with clinical research teams ... participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Start-Up Specialist -… more
- Guthrie (Sayre, PA)
- …Responsibilities for program development include assisting with feasibility, site selection, IRB document review , and corresponding with investigators, IRB ... Guthrie and the data submission to the sponsor. Guthrie's updates include patient protocol enrollments, document submissions to IRB , and event management of… more