- J&J Family of Companies (Irvine, CA)
- …technical/ clinical product development experience required + In-depth knowledge of ophthalmic clinical trial design, regulatory affairs , and Good ... Clinical Practice (GCP), Inclusive Leadership, Leadership, Ophthalmology, Regulatory Affairs Management, Relationship Building, Scientific Research,… 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)
- …protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Job Description Clinical Research Coordinator BWith ... health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C Job Profile Title Clinical Research Coordinator B… 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
- Insight Global (Beachwood, OH)
- …plans and protocol review cycles. o Submit and manage regulatory applications ( FDA and other global agencies). - Clinical Execution & Oversight o Oversee ... of clinical trial design, including randomized controlled trials and regulatory standards ( FDA , IRB). . Strong leadership, communication, and interpersonal… more
- Philips (Cambridge, MA)
- …other publications to advance industry knowledge and visibility. + Manages the Clinical Affairs Annual Operating Plan (AOP), overseeing fiscal allocations, ... broader ecosystem and represents Philips internally and externally as an ambassador for Clinical Affairs . + Oversees the handling of audit requests, responses,… more
- Lilly (Indianapolis, IN)
- …This position requires close collaboration with cross-functional partners including medical affairs , clinical operations, regulatory , statistics and data ... vision and comply with current regulations, laws, guidance (eg FDA , ICH, and CPMP etc.), Good Clinical ...assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions,… more
- University of Pennsylvania (Philadelphia, PA)
- …organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices ... of all external review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the Director is responsible… more
- J&J Family of Companies (Danvers, MA)
- … Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be ... Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents,… more