- Terumo Neuro (Aliso Viejo, CA)
- …execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site ... with the protocol, GCP, company SOPs, and all applicable regulations (eg, FDA ). + Understand, read, prepare, and deploy study documentation including, informed… more
- HCA Healthcare (Richmond, VA)
- …and enters data into study specific case report forms or electronic data capture systems** + **Generates and tracks drug shipments, device shipments, and supplies as ... + **Communicates all protocol-related issues to appropriate study colleagues or manager ** + **Attends study specific on site meetings, investigator meetings,… more
- HCA Healthcare (Port Charlotte, FL)
- …and enters data into study specific case report forms or electronic data capture systems + Generates and tracks drug shipments, device shipments, and supplies as ... Communicates all protocol-related issues to appropriate study colleagues or manager + Attends study specific on site meetings, investigator...medical issues for guidance + Assists sponsor and US FDA audit teams + Reviews and responds to any… more
- Rush University Medical Center (Chicago, IL)
- …neurology movement disorder research studies under the direction of the research manager and primary investigators, working collaboratively with a team of peer ... Knows the basic rules and guidelines from NIH and FDA that apply to research. * Project & Time...data into study case report forms and/or electronic data capture system and respond to queries in a timely… more
- Lundbeck (Deerfield, IL)
- …professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that ... + Led high-quality advisory boards and roundtables in rare diseases, ensuring capture of relevant and actionable insights + Oversaw the design and delivery… more
- University of Colorado (Aurora, CO)
- …ensure compliance with requirements of the Food and Drug Administration ( FDA ), study protocols, department, hospital/clinical standard operating procedures and other ... Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses + Participate in subject recruitment efforts, including… more
- US Tech Solutions (South San Francisco, CA)
- …The Clinical Research Coordinator, under the oversight of the Clinical Trial Manager and PI, is responsible for independently conducting clinical research sessions ... maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system. + Maintain Investigator Site Files and support Sponsor… more
- University of Utah (Salt Lake City, UT)
- …study support staff under the direction of the PRISM - PSTO /Adapt clinical research manager , Disease Center leads and the breast and gyn programs manager to ... deviations. + Documents and reports all protocol deviations to program manager and/or senior clinical research coordinator, reconciles test article accountability at… more
- University of Utah (Salt Lake City, UT)
- …team of study support staff under the direction of the PSTO research manager to support the Principal Investigator's research objectives. Depending on study needs, ... deviations. + Documents and reports all protocol deviations to program manager and/or senior clinical research coordinator, reconciles test article accountability at… more
- University of Pennsylvania (Philadelphia, PA)
- …in a highly collaborative team environment with other research coordinators, a lab manager , program manager , and investigators to help advance the research ... in accordance with ALCOA-C. Enter data in electronic data capture systems. Perform data QC and address queries. Show...and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Clinical Research Coordinator B Clinical… more