- University of Pennsylvania (Philadelphia, PA)
- …to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and ... and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B (Department of Gastroenterology) Job Profile Title Clinical… more
- Stryker (Columbia City, IN)
- Stryker is hiring a **Staff Specialist, Regulatory Affairs ** , ( **Hybrid** ) to join our Regulatory Affairs team in **Columbia City, Indiana** . This ... to trauma and extremities. + Evaluate quality, preclinical, and clinical data to ensure submission readiness. + Prepare and...Minimum of 2-3 years of experience in Medical Device Regulatory Affairs . **Preferred** + Strong project management,… more
- Georgetown Univerisity (Washington, DC)
- …science, life science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + Familiarity with regulatory ... in ensuring regulatory compliance and oversight of a portfolio of clinical trials in the Center for Translational Transplant Medicine (CTTM) and the Department… more
- Orchard Therapeutics (Boston, MA)
- …collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory , Medical Affairs , Pharmacovigilance and other teams supporting ... development, the clinical development plans, managing the clinical studies, drive the regulatory documentations/presentations, writing and executing… more
- AbbVie (Irvine, CA)
- …and not on FDA promotional considerations. + Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and agency ... pharmaceutical company or practicing as an attorney for the FDA , or any combination of the above. + Individual...regulations and guidance around innovator drug development, including on clinical trial design and study requirements, regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title Clinical Research Coordinator A ... This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate...+ Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality, and Medical Affairs -this leader will ensure ... activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality, and Medical Affairs -this leader will ensure… more
- University of Pennsylvania (Philadelphia, PA)
- …institutional and sponsor systems. The ideal candidate will bring prior experience supporting clinical trials under FDA IND or IDE oversight, particularly those ... institutional and sponsor systems. The ideal candidate will bring prior experience supporting clinical trials under FDA IND or IDE oversight, particularly those… more
- WMCHealth (Valhalla, NY)
- …reimbursement requests at the conclusion of patient's participation in protocol + Regulatory Affairs : Responsible for preparing and submitting new research ... Clinical Research Coordinator Company: NorthEast Provider Solutions Inc....progress from start-up to close-out activities in accordance with FDA , GCP, ICH guidelines, local regulations and corporate policies.… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B/C Job Profile Title Clinical Research Coordinator A ... Research Coordinator (CRC) will support the conduct of Phase I-IV clinical trials, registries, and NIH-funded research studies for the Pulmonary Vascular Disease… more