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Children's Hospital Colorado Clinical Research Regulatory Specialist 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 .and. 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: CCBD Research CenterHours per week: 40, eligible for benefitsShift: Monday - Friday 8:30am to 5:00pmJob OverviewThe Clinical Research Regulatory Specialist is responsible for the managementof clinical research protocol documents and activity from initial submissionthrough study closure. The primary focus is on the development,submission, maintenance, filing and reporting of regulatory documentswhile achieving and maintaining compliance with all internal, external andfederal policies and regulations that apply to research involving humansubjects. Provides regulatory guidance and direction to all members of theresearch team at Children's Hospital Colorado to ensure compliance with allapplicable policies, procedures and regulations.The Center for Cancer and Blood Disorders (CCBD) has an opening for aClinical Research Regulatory Specialist in our Experimental TherapeuticsProgram (ETP). The ETP brings early phase (Phase 1 and Phase 2)cancer and blood disorder trials to our pediatric patients. Experience inPhase I and II trials, INDs, including eINDs, is desired as isfamiliarity with regulations governing research in pediatric, youth andyoung adult populations. If you are a dedicated team player, we want tohear fResponsibilitiesPOPULATION SPECIFIC CARENo direct patient care.ESSENTIAL 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.Independently develops and submits Study Institutional Review Board (IRB)documents such as consent forms and protocols for initial submissions,protocol amendments, and continuing reviews.Independently maintains appropriate study documentation including regulatorybinders and enrollment logs.Responsible for preparing, maintaining and updating regulatory binders forreview by internal or external monitoring/auditing groups; available toauditors and monitors to discuss regulatory issues at each visit; able toexplain internal regulatory processes and Standard Operating Procedures(SOPs) as needed.Submits Adverse Event Reports and Protocol Deviations according toinstitutional review board and sponsor-specific reporting requirements.Assesses current departmental processes and SOPs; provides suggestions forimprovement.Enters protocol specific data into required IRB and Children's HospitalColorado systems.Assists research team members in assessing and optimizing departmentalworkflows.Assists in training/mentoring new staff, providing constructive feedbackto other team members as necessary.Maintains understanding of the professional guidelines and code of ethicsrelated to clinical research conduct, and maintains ability to summarize andclarify these for study teams.Maintains study compliance with Institutional Review Board, CHCO and otherpolicies.Oversees the maintenance and delegation of authority logs and documentation oftraining of key personnel on assigned studies.Communicates clearly and in a professional