- University of Pennsylvania (Philadelphia, PA)
- …requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional ... collaborative research environment alongside a team of study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance… more
- University of Pennsylvania (Philadelphia, PA)
- …subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating ... to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and essential… more
- University of Pennsylvania (Philadelphia, PA)
- …trial agreements and associated budgets. The Program Manager will be the principal support in protocol development consistent with the Division's overall research ... and explanted devices required per protocol. + Protocol Development: Principal support in the development of Physician-Modified Investigational Device Exemptions… more
- University of Pennsylvania (Philadelphia, PA)
- …Daily management of laboratory tools, documentations and processes to ensure regulatory compliance and timely completion of project/program deliverables, with close ... Closely collaborating with other research investigators of the group and the Principal Investigator (PI) on experimental work set ups in accordance to established… more
- Edwards Lifesciences (Harrisburg, PA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and … more
- University of Pennsylvania (Philadelphia, PA)
- …directly to the TBIRI Program Lead under the supervision of the TBIRI Principal Investigators. The CRC will be responsible for the coordination and execution of ... have prior experience conducting clinical research while adhering to applicable regulatory policies for patient and data protection. Responsibilities include, but… more
- J&J Family of Companies (Spring House, PA)
- …company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior Local Trial Manager actively contributes to ... ensures that the trial is in compliance with local regulatory requirements. + Works with SM to ensure CAPA...of job functions. May perform other duties as assigned. ** Principal Relationships:** + Primary Reporting Structure: Reports to a… more
- University of Pennsylvania (Philadelphia, PA)
- …& consent, visit scheduling, medication administration, data collection, & regulatory compliance with institutional & sponsor requirements. Position is contingent ... Research Nurse D(Project Manager) + Collaborate with Research Team and Principal Investigators to initiate study procedures for new investigator-initiated trials… more
- University of Pennsylvania (Philadelphia, PA)
- …trials performed by the physicians of Penn Cardiology and collaborates with principal investigators to assure research activities are conducted with the currently ... of the study. + Creates and maintains research data, regulatory files, subject data and patient tracking databases. +...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO. This position ... II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more