Job ID83190

　　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 Director of Research Compliance is responsible for planning,implementation, oversight and evaluation of the Children's HospitalColorado research compliance program to ensure all research activities arecompliant with internal research policies and applicable federal, state,and local research regulations. You will play a pivotal role in overseeingand managing our research and sponsored programs. You will have theopportunity to work closely with faculty, research operations staff, andother campus stakeholders in partnership with our Child Health ResearchEnterprise and contribute to the overall success of our organization. You'llleverage your expertise on pre-award and post-award administration ofexternally funded grants and related research functions, with specificemphasis on Uniform Guidance, Human Subjects Research, and InstitutionalReview Board (IRB) compliance. You will be responsible for overseeing andproviding guidance to our health system's Conflict of Interest program,including collaborating with the Multiple Institutional Review Board'sconflict of interest committee to review disclosures from investigators anddevelop effective management plans. If you are passionate about promotingethical practices and ensuring regulatory compliance within the medicalresearch field, we invite you to apply for this exciting opportunity.

　　Qualifications

　　EDUCATION - Master's degree.EXPERIENCE- Five (5) years of progressively responsible experience inhuman subject protections, clinical research, grants and contractsrequired. Plus, a minimum of three (3) years ofsupervisory/leadership experience is required. Proficiency with federal,state and local regulations related to clinical research protocols,practices and human subject protection.EQUIVALENCY- In lieu of a master's degree, a bachelor's degree with(2) two additional years of professional experience in a supervisory rolein research compliance (or similar position applying complex regulatoryrequirements in research) will serve as an equivalency. CERTIFICATION(S) - Good Clinical Practice (GCP) and Human SubjectProtection certification awarded by the Collaborative Training Initiative(CITI) required within 60 days of hire.

　　Responsibilities

　　An employee in this position may be called upon to do any or all of thefollowing essential functions. These examples do not include all functionswhich the employee may be expected to perform.Responsible for developing regulatory compliance through training,education, strategic risk assessments, study auditing and monitoring incollaboration within CHCO and its affiliates. Leads the organization-wideresearch compliance program, working closely with various leaders andpartners, organizations, universities, medical centers,institutions, and funding agencies.Designs, develops, implements and oversees a portion of the annualcorporate compliance plan designed to ensure effective mitigation andmanagement of compliance risks. Completes a risk assessment for researchcompliance.Establishes and maintains a process to address, manage and resolve researchcompliance issues, including allegations of research misconduct ornoncompliance with sponsor requirements, inquiries and complaints frompatients or families and reports to the Compliance Hotline.Performs research compliance investigations and reviews. Coordinates theinvestigation and response to any research compliance review or investigation