- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Associate Director , Regulatory Job Profile Title Associate Director , Clinical Research ... Regulatory Job Description Summary With the oversight of the Director , the Associate Director for Regulatory Affairs will oversee the portfolio of clinical… more
- Guthrie (Sayre, PA)
- …of a physician-administrator leadership model. The dyad pairs the Executive Director of Research (physician leader-HPA) with a senior administrative executive to ... Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA, IRB, GCP , ICH). + Experience in integrating clinical research into health system… more
- IQVIA (Philadelphia, PA)
- …Overview:** IQVIA is seeking an experienced Associate Clinical Project Management Director /Trial Delivery Manager (TDM) to lead and coordinate global and regional ... for regulatory submissions. + Support Health Authority inspections and internal audits . **Training & Meetings** + Develop and deliver trial-specific training… more
- Penn Medicine (West Chester, PA)
- …will comply with all policies relating to UPHS, JCAHO, Good Clinical Practice ( GCP ) and other regulatory standards. Responsibilities: + Care for subjects in all age ... study team and in accordance with research guidelines and GCP . Coordinate activities of oncology team in caring for...sponsors and CROs + participation in the conduct of audits by study sponsors, CROs, the FDA, Cooperative Study… more
- WellSpan Health (York, PA)
- …eligibility and informed consent documentation requirements are met as per the GCP , FDA and IRB guidelines. Registers and accomplishes randomization of patients ... is maintained and federal guidelines are met. + Coordinates all site visit audits . Gathers records and other necessary materials required for audits . Reviews… more
- University of Pennsylvania (Philadelphia, PA)
- …in the CRU that requires RN involvement, will directly report to the Director of Clinical Research, collaborate with study teams, monitor, document, and educate ... Phases of clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, the University...study team and in accordance with research guidelines and GCP . Coordinate activities of the radiation oncology team in… more