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 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 Director of Research Compliance is responsible for planning, implementation, oversight and evaluation of the Children's Hospital Colorado research compliance program to ensure all research activities are compliant with internal research policies and applicable federal, state, and local research regulations. You will play a pivotal role in overseeing and managing our research and sponsored programs. You will have the opportunity to work closely with faculty, research operations staff, and other campus stakeholders in partnership with our Child Health Research Enterprise and contribute to the overall success of our organization. You'll leverage your expertise on pre-award and post-award administration of externally funded grants and related research functions, with specific emphasis on Uniform Guidance, Human Subjects Research, and Institutional Review Board (IRB) compliance. You will be responsible for overseeing and providing guidance to our health system's Conflict of Interest program, including collaborating with the Multiple Institutional Review Board's conflict of interest committee to review disclosures from investigators and develop effective management plans. If you are passionate about promoting ethical practices and ensuring regulatory compliance within the medical research field, we invite you to apply for this exciting opportunity.

Qualifications

EDUCATION - Master's degree. EXPERIENCE- Five (5) years of progressively responsible experience in human subject protections, clinical research, grants and contracts required. Plus, a minimum of three (3) years of supervisory/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 role in research compliance (or similar position applying complex regulatory requirements in research) will serve as an equivalency. CERTIFICATION(S) - Good Clinical Practice (GCP) and Human Subject Protection 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 the following essential functions. These examples do not include all functions which the employee may be expected to perform. Responsible for developing regulatory compliance through training, education, strategic risk assessments, study auditing and monitoring in collaboration within CHCO and its affiliates. Leads the organization-wide research compliance program, working closely with various leaders and partners, organizations, universities, medical centers, institutions, and funding agencies. Designs, develops, implements and oversees a portion of the annual corporate compliance plan designed to ensure effective mitigation and management of compliance risks. Completes a risk assessment for research compliance. Establishes and maintains a process to address, manage and resolve research compliance issues, including allegations of research misconduct or noncompliance with sponsor requirements, inquiries and complaints from patients or families and reports to the Compliance Hotline. Performs research compliance investigations and reviews. Coordinates the investigation and response to any research compliance review or investigation