- University of Pennsylvania (Philadelphia, PA)
- …of a multidisciplinary team and will report to the Penn FTD Center Regulatory Project Manager . Qualifications + High School diploma and 2 years of experience ... Research Regulatory Specialist A will work collaboratively with study coordinators, project managers, and investigators in the Penn FTD Center; Participates in… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …including a CRM software (Salesforce). Essential Functions + Work with Salesforce project manager , implementation consultants, business SMEs and technical teams ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- University of Pennsylvania (Philadelphia, PA)
- …and various sponsors. This position will report directly to the Research Manager and work directly with Physician Investigators ("PI") on clinical research ... the conduct of audits by study sponsors, CROs, the FDA , the Eastern Oncology Group, the University of Pennsylvania's...projects and assist unit managers in overseeing execution of project timelines as well as completion of study related… more
- Fujifilm (Harrisburg, PA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- University of Pennsylvania (Philadelphia, PA)
- …is expected to perform the duties above with more limited supervision from the project manager . In addition, will develop complex documents such as protocols and ... safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA , and GCP guidelines. Clinical Coordinator B, in addition to the above,… more
- University of Pennsylvania (Philadelphia, PA)
- …environment alongside a team of study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance the dermatology research ... compliance and data quality. * Adhere to all University of Pennsylvania, FDA and GCP guidelines. * Effectively and independently managing multiple trials while… more
- Parexel (Harrisburg, PA)
- …(SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for ... (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study...of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent… more
- BioFire Diagnostics, LLC. (Philadelphia, PA)
- …microbiology, molecular biology, immunology); as such, you will be: Member of the project teams for developing or modifying these products. The preferred contact and ... GiCS (global industry customer service) representatives, manufacturing site quality manager , program directors and Industrial Applications Quality Managers. + Be… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... and other projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities including but not… more
- Cardinal Health (Harrisburg, PA)
- …(General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), DSCSA(Drug ... and implement control framework across it + Hands-on experience with GRC platforms, project management tools, and service management systems, with a focus on scaling… more