- Medtronic (Memphis, TN)
- …Marketing, Manufacturing, Supply Chain and end-users (surgical staff) to capture functional requirements and user workflows + Require familiarity with ... relevant FDA and OUS regulations as well as ISO and...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Dialysis Clinic, Inc. (Albany, GA)
- …CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture , etc.) as applicable. + Perform detailed medical chart review and ... clinical trial protocol. + Participate in routine monitoring visits from Sponsor and/or FDA audits. + Conduct clinical trials in 2 or more outpatient dialysis units… more
- University of Pennsylvania (Philadelphia, PA)
- …and participant binders in accordance with ALCOA-C. * Enter data in electronic data capture systems. * Perform data QC and address queries. * Show vigilance in ... compliance and data quality. * Adhere to all University of Pennsylvania, FDA and GCP guidelines. * Effectively and independently managing multiple trials while… more
- University of Colorado (Aurora, CO)
- …administrative lead for clinical research. + Work with DFA, clinical research manager and clinical trials finance coordinator to monitor and execute finance duties ... a clinical research setting + Experience with electronic data capture systems (eg EMR or EHR and data management...local and central IRB submissions, maintaining clinical trial records, FDA submissions, and acting as a liaison between industry,… more
- Seattle Children's (Seattle, WA)
- …the areas of clinical trial operations and 5 years in a leadership/ manager role with increasing responsibility overseeing early phase oncology trials; developing, ... implementing, and leading early-phase (I/II) clinical trials. and FDA regulations and guidelines including the IND Direct experience...**About Us** **Hope. Care. Cure. These three simple words capture what we do at Seattle Children's - to… more
- Rush University Medical Center (Chicago, IL)
- …and Good Documentation Practices. * Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research. * Strong project ... data into study case report forms and/or electronic data capture system and respond to queries in a timely...* Partner with PI(s), sponsor, compliance, clinical staff and manager to identify and improve more complex processes as… more
- Houston Methodist (Houston, TX)
- …accurate information in Source Documents, Case Report Forms, Electronic Data Capture portals and Clinical Trial Management System following established procedures. ... regulatory documents. + Under the direction of Research Nurse/Clinical Trial Manager /Physician, captures and reports Adverse Events (A/E) or Serious Adverse Events… more
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