- 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
- 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 (Nashville, TN)
- …user feedback, and best practices that can be brought back to internal teams ( Clinical Affairs , R&D, Medical Affairs ). + Troubleshoots and resolves issues ... This role also acts as a critical link between Clinical Research, Medical Affairs , Research and Development,...product advisory boards. + Ensure adherence to study protocols, regulatory requirements (GCP, ISO, FDA ), and Philips… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …**The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs , compliance, and clinical support professionals dedicated ... Warfighter. The ORA** **provides full-service,** **oversight, and consultation for** ** regulatory , clinical , non- clinical , manufacturing, data management,… more
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks...intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best… 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
- Parexel (Little Rock, AR)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies...Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the Clinical… more
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks...intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best… more
- Abbott (Sylmar, CA)
- …+ Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs , Engineering, Marketing and Regulatory ... , currently has an onsite opportunity for a **R&D Clinical Engineer.** As a global leader in Cardiac Rhythm...requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC, Biostatistics, GCO, in the execution of ... you'll spend your day** + Designs, conducts, and reports clinical trials in line with the development, regulatory...Investigator or Principal Investigator. + May have been a FDA reviewer for disease area. Job-Specific Competencies: + Excellent… more