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Job ID88184

LocationAurora, Colorado

Full/Part TimeFull-Time

Regular/TemporaryRegular

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Why Work at Children's....

Here, it's different. Come join us. Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years. Here, the nation's brightest nurses, physicians, scientists, researchers, therapists, and care providers are creating the future of child health. With an optimist's outlook, a trailblazing spirit, and a celebrated history, we're making new strides every day. We've been Magnet-designated four times by the American Nurses Credentialing Center and are consistently recognized among the best of the best pediatric hospitals with #1 rankings in Colorado and the region by U.S. News & World Report. As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 11 specialty care centers, 1,300+ outreach clinics and more than 10,000 healthcare professionals representing the full spectrum of pediatric care specialties. Here, we know it takes all of us, every role, to deliver the best possible 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 different identities and backgrounds can nurture creativity and innovation. We know we can see, treat, and heal children better when our team reflects the diversity of our patient population. We strive to attract and retain diverse talent because we know a truly inclusive and equitable workforce will help us one day realize our most basic calling: to heal every child who comes through o A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it's different.

Job Overview

The Senior Clinical Research Regulatory Specialist is responsible for the management of complex research protocol documents and activity from initial submission through study closure. The primary focus is on the development, submission, maintenance, filing and reporting of regulatory documents while achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to research involving human subjects. Provides advanced regulatory guidance and direction of complex matters to all members, including to less experienced Regulatory Specialists, of the research team at Children's Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations. The ETP (Experimental Therapeutics program) is the CCBD (Center for Cancer and Blood Disorders) early phase (phase I/II) clinical trial program. ETP offers investigational treatments for children, adolescents, and young adults with recurrent/refractory illness or with a diagnosis that has no reasonable cure. This program works with cooperative groups, consortiums, pharmaceutical (industry) studies, and PI initiated studies. The team member in this position is key to the ETP Regulatory team in the startup of early phase clinical trials (compliance, startup of studies, amendments, continuing reviews, and other job essential functions of the regulatory specialist). This position also supports other ETP regulatory team members in the completion of IND submissions including (IND/IDEs, sINDs, eINDs), IRB submissions and regulatory compliance. The successful applicant will have a strong background as a regulatory specialist that compliments the needs of the ETP team.

Additional Information

Department: RI-CCBD Clinical Research Hours per week: 40, eligible for benefits Shift: This is an exempt position. Monday - Friday, 8am to 4:30pm. Work hours may vary due to department needs. This position may have the possibility of being hybrid upon successful completion of departme t 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 be considered in lieu of minimum requirements.

Responsibilities

POPULATION SPECIFIC CARE No direct patient care. ESSENTIAL FUNCTIONS An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions 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 regulatory binders and enrollment logs.