- University of Pennsylvania (Philadelphia, PA)
- …trials. + Prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees. + Prepare and process all ... Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include… more
- System One (Pittsburgh, PA)
- …with study participants and potential community recruits. + Assists with and adheres to Institutional Review Board ( IRB ) renewal, modification, and ... & consent and enrollments, data collection/entry, and compliance with the regulatory process. Responsibilities: + Will work closely with the Principal Investigators… more
- Guthrie (Sayre, PA)
- …Ensure IRB operations align with federal (OHRP, FDA), state laws and institutional policies. Provides guidance to the IRB in developing policies and ... domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports research and scholarly activities related...procedures, interpreting regulations, obtaining Foundation Board approval of new IRB members, and… more
- Guthrie (Sayre, PA)
- …Responsibilities for program development include assisting with feasibility, site selection, IRB document review , and corresponding with investigators, IRB ... sponsor training, training team members to delegated duties, supporting regulatory specialist with sponsor communications, maintaining study supply inventory, and… more
- University of Pennsylvania (Philadelphia, PA)
- …multiple locations across the health system, biospecimen processing, and regulatory management. This position involves working directly with several Investigators ... and exams, as well as submitting modifications and continuing reviews to the IRB . The position involves abstracting information from medical records and data entry.… more
- University of Pennsylvania (Philadelphia, PA)
- …maintained in a secure manner. + Resolve regulatory related queries with IRB , study sponsors. Review Research bills/invoices for accuracy for payment from ... drugs/devices/equipment are maintained in a secure manner. + Resolve regulatory related queries with IRB , study sponsors....manner. + Resolve regulatory related queries with IRB , study sponsors. Review Research bills/invoices for… more
- University of Pennsylvania (Philadelphia, PA)
- …processing and shipping of biofluids; Data entry; Query management; Maintaining regulatory documents and binders for clinical trials; Assisting with invoicing for ... clinical trials; Assisting with preparing and submitting IRB documents for clinical trials; Pre-trial and start-up activities such as creation of source… more
- University of Pennsylvania (Philadelphia, PA)
- …communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate ... communication with sponsors, investigators, and cross-functional research teams (including regulatory and data management teams), ensuring protocol compliance and… more
- Norstella (Harrisburg, PA)
- …on clinical trials, drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver vital advantage when making ... global pharma and CROs. From drug and device discovery and development to regulatory approval, and from product launch to lifecycle management, we provide the… more
- Penn Medicine (Lancaster, PA)
- …for all research staff including renewals and new training. + Assist with regulatory compliance including preparation of IRB materials for approval and ... conducting research studies and clinical trials per Federal, State and Institutional guidelines. The Trauma Research Associates responsible for all research related… more