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Children's Hospital Colorado Clinical Research Coordinator in Aurora, Colorado

Job ID67691LocationAurora, ColoradoFull/Part TimeFull-TimeRegular/TemporaryRegularWhy Work at Children's....Here, it's different. Come join us.Children's Hospital Colorado has defined and delivered pediatric healthcareexcellence for more than 100 years.Here, the nation's brightest nurses, physicians, scientists,researchers, therapists and care providers are creating the future of childhealth. With an optimist's outlook, a trailblazing spirit and a celebratedhistory, we're making new strides every day.We've been Magnet-designated three times by the American NursesCredentialing Center and are consistently recognized among the nation's top10 pediatric hospitals by U.S. News and World Report.As a national leader in pediatric care, we serve children and families fromall over the nation. Our System of Care includes four pediatric hospitals,12 specialty care centers, 400+ outreach clinics and 7,000 healthcareprofessionals representing the full spectrum of pediatric care specialties.We need your expertise.A career at Children's Colorado will challenge you, inspire you, andmotivate you to make a difference in the life of a child. Here, it'sdifferent. Do you have what it takes?Additional InformationDepartment: RI-CCROHours per week: 40, eligible for benefitsJob OverviewThe Clinical Research Coordinator is responsible for participating in theday-to-day operations of assigned clinical research programs and/or studiesconducted by Principal Investigators (PIs) at the University of ColoradoAnschutz Medical Campus. Performs a variety of administrative and operationalduties involved in the collection, compilation, documentation and reviewof clinical research data. Supports the achievement of research programand/or study objectives. Works under close supervision.The Clinical Research Coordinator will support the research portfolio in theCardiac Catheterization Laboratory. This portfolio is typically industrysponsored device research.ResponsibilitiesPOPULATION SPECIFIC CARENeonate -Infancy - >30 days to 1yrToddlers - >1yr to 3yrsPre-Schoolers - >3yrs to 5yrsSchool age - >5yrs to 13yrsAdolescent - >13yrs to 18yrsAdult - >18yrs to 65yrsESSENTIAL FUNCTIONSAn employee in this position may be called upon to do any or all of thefollowing essential functions. These examples do not include all of thefunctions which the employee may be expected to perform.Submits studies for review and approval and provides status updates throughoutthe startup process. Assists regulatory team with Institutional Review Board(IRB) preparation and submission.Screens, schedules, consents participants in a variety of clinicalresearch programs and/or studies. Explains the difference between clinicalactivities and research activities, risk and benefits of study participationto participants.Assists with developing or develops protocol-specific systems and documentsincluding process flows, training manuals, Standard Operating Procedures(SOPs) and Case Report Forms (CRFs). Maintains subject leveldocumentation and prepares documents, equipment and/or supplies.Prepares for and takes part in site initiation, monitoring, closeoutvisits, and document storage activities. Conducts and documents visits andtesting/interviews according to all regulatory and organizational protocols.Collects, prepares, processes, ships and maintains inventory of researchspecimCollects information to determine feasibility, recruitment and retentionstrategies. Employs strategies to maintain participant recruitment andretention rates and assists participants with individual needs.Collects, prepares and/or processes Adverse Event (AE) information perprotocol and provides input for AE reports. May complete and submit AEreports, according to institution and sponsor-specific reporting requirements.Provides input for and assists with developing IRB related documents.Maintains or collaborates to maintain appropriate documentation.Assists with identifying issues related to operational efficiency and sharesresults wit