Job Information
Children's Hospital Colorado Clinical Research Regulatory Specialist in Aurora, Colorado
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Job ID89410
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 Clinical Research Regulatory Specialist is responsible for the management of clinical 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 regulatory guidance and direction to all members of the research team at Children's Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations. This position will be within the centralized research infrastructure at Children's Hospital Colorado, within the Research Institute. This position will support several service lines within the institution.
Additional Information
Department: CCHRI - Operations 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 is a hybrid position.
Qualifications
Education:Bachelor's degree in a related field is required. Experience:Minimum of three (3) years of related experience is required. Equivalency:Minimum of seven (7) years of related experience may be considered in lieu of minimum requirements. At least two (2) years of direct regulatory experience is preferred.
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. Respo sible for preparing, maintaining and updating regulatory binders for review by internal or external monitoring/auditing groups; available to auditors and monitors to discuss regulatory issues at each visit; able to explain internal regulatory processes and Standard Operating Procedures (SOPs) as needed. Submits Adverse Event Reports and Protocol Deviations according to insitutional review board and sponsor-specific reporting requirements. Assesses current departmental processes and SOPs; provides suggestions for improvement. Enters protocol specific data into required IRB and Children's Hospital Colorado systems. Assists research team members in assessing and optimizing departmental workflows.