Children's Hospital Colorado Clinical Research Coord Sr - 60602 in Aurora, Colorado

Why Work at Children's....Children's Hospital Colorado has defined and delivered pediatric healthcareexcellence for more than 100 years. Founded in 1908, Children's Coloradois a leading pediatric network entirely devoted to the health and well beingof children. Continually recognized as one of the nation's outstandinghospitals by U.S. News & World Report, Children's Colorado is known bothfor its nationally and internationally recognized medical, research andeducation programs as well as the full spectrum of everyday care for kidsthroughout Colorado and surrounding states. With more than 1,000 healthcareprofessionals representing the full spectrum of pediatric specialties,Children's Colorado Network of Care includes its main campus, 16Children's Care Centers and more than 400 outreach clinics.A career at Children's Colorado will challenge you, inspire you, andmotivate you to make a difference in the life of a child.Additional InformationDepartment: Pulmonary MedicineHours per week: 40, eligible for benefitsShift: M-F 8-5Job OverviewThe Clinical Research Coordinator Senior is responsible for participating inthe day-to-day operations of assigned clinical research programs and/orstudies conducted by Principal Investigators (PIs) at the University ofColorado Anschutz Medical Campus. Performs a variety of administrative andoperational duties involved in the collection, compilation, documentationand review of clinical research data. Supports the achievement of researchprogram and/or study objectives. Leads others in navigating the clinicalresearch environment and participates in a variety of departmental and/ordivisional initiatives. Provides oversight to Clinical Research Coordinatorsand other related team members. Works under general supervision.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 FunctionsSubmits 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.Develops and optimizes protocol-specific systems and documents includingprocess flows, training manuals, Standard Operating Procedures (SOPs)and Case Report Forms (CRFs). Maintains subject level documentation andprepares documents, equipment and/or supplies.Serves as a resource for and takes part in site initiation, monitoring,closeout visits, document storage activities, and related training,creation of Standard Operating Procedures (SOPs) and implementation ofoperational plans. Conducts and documents visits and testing/interviewsaccording to all regulatory and organizational protocols. Collects,prepares, processes, ships and maintains inventory of research specimens.Collects information to determine feasibility, recruitment and retentionstrategies. Employs, evaluates and assists with the implementation ofinnovative solutions to maximize recruitment and retention. Assistsparticipants with individual needs.Collects, prepares and/or processes Adverse Event (AE) information perprotocol and provides input for AE reports. Completes and submits AEreports, according to institution and sponsor-specific reportingrequirements. Serves as a resource regarding institutional andsponsor-specific reporting requirements.Develops IRB related documents. Maintains or collaborates to maintainappropriate documentation.Assists with identify issues related to operational efficiency and sharesresults with leadership.Maintains compliance with institutional requirements and policies. Developsand maintains a familiarity with the ethical conduct of research andsafeguards needed when con