Job ID82725

　　LocationAurora, Colorado

　　Full/Part TimeFull-Time

　　Regular/TemporaryRegular

　　Why 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 ofchild health. With an optimist's outlook, a trailblazing spirit, and acelebrated history, we're making new strides every day.We've been Magnet-designated four times by the American Nurses CredentialingCenter and are consistently recognized among the best of the best pediatrichospitals with #1 rankings in Colorado and the region by U.S. News & WorldReport.As a national leader in pediatric care, we serve children and families fromall over the nation. Our System of Care includes four pediatric hospitals,11 specialty care centers, 1,300+ outreach clinics and more than10,000 healthcare professionals representing the full spectrum of pediatriccare specialties.Here, we know it takes all of us, every role, to deliver the bestpossible care to each child and family we treat.That's why we build our teams toward a foundation of equity in access,advancement, and opportunity. We know teams of individuals with differentidentities and backgrounds can nurture creativity and innovation. We know wecan see, treat, and heal children better when our team reflects thediversity of our patient population. We strive to attract and retain diversetalent because we know a truly inclusive and equitable workforce will help usone day realize our most basic calling: to heal every child who comesthrough oA 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.

　　Job Overview

　　The Senior Clinical Research Regulatory Specialist is responsible for themanagement of complex research protocol documents and activity from initialsubmission through 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 advanced regulatory guidance and direction of complexmatters to all members, including to less experienced RegulatorySpecialists, of the research team at Children's Hospital Colorado toensure compliance with all applicable policies, procedures and regulations.This position will support the Neuro-Oncology and Surge clinical trialprograms. This program participates in industry, numerous IIT andcompassionate use studies from pilot and feasibility studies up through phaseIII. The team member in this position is key to supporting the clinical trials(compliance, startup of studies, amendments, continuing reviews,etc.) in addition to performing other job essential functions of theregulatory specialist. The successful applicant will have a strong backgroundas a regulatory specialist that compliments the needs of the Neuro-Oncology& S

　　Additional Information

　　Department: RI-CCBD Clinical ResearchHours per week: 40, eligible for benefitsShift: Monday - Friday, 8am to 4:30pm. Work hours may vary due todepartment needs. This position may have the possibility of being hybrid uponsuccessful completion of department on-boarding/training and job performance.

　　Qualifications

　　Education: Bachelor's degree in a related field is required.Experience: Minimum of five (5) years of related experience is required.Equivalency: Minimum of nine (9) years of related experience may beconsidered in lieu of minimum requirements.

　　Responsibilities

　　POPULATION 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 SOPs as needed.Submits Adverse Event Reports and Protocol Deviations according toinstitutional review board and sponsor-specific reporting requirements. Servesas a subject matter expert on reporting requirements.Works closely with investigators in the preparation and submission ofInvestigational New Drug (IND) applications to the U.S. Food & DrugAdministration (FDA).