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 our doors.

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.

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.

• 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.

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.

1. 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.
2. 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.
3. 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.
4. Performs research compliance investigations and reviews. Coordinates the investigation and response to any research compliance review or investigation conducted by regulatory bodies.
5. Leads internal compliance auditors for compliance with approved protocols, federal regulations and policies. Meets with Principal Investigators and other organizational leaders to discuss results of auditing and monitoring activities. Assists with follow up and training of a formal Corrective Action Plan.
6. Coordinates the preparation of reports of non-compliance. Ensures all external reporting required under applicable research regulations is completed and submitted in a compliant and timely manner.
7. Develops, reviews, implements and facilitates research compliance policies and procedures, including but not limited to research conduct policies and procedures, research misconduct, protection of human subjects, and responsible conduct of research. Aids in documenting results of analyses and action plans.
8. Develops and implements research compliance education and training, in cooperation with organizational stakeholders, for Principal Investigators and all members involved in research.
9. Provides consultation services organization-wide on the application and implementation of current research regulations and research compliance program policies and procedures. Monitors regulatory, legal and industry developments for implementation in the compliance program. Analyzes the impact of proposed changes in the overall assessment and in the research compliance plan.
10. Reviews laws and regulations regarding human subject research. Continues to advance appropriate knowledge base and skills.
11. Assists with clinical study contract reviews or other contracts for compliance with FDA, NIH, CMS and other regulatory federal and state agencies. Maintains the system's research-related assurances and accreditations with the appropriate government agencies.

SCOPE & LEVEL

Guidelines: Guidelines are in in the form of stated vision and goals for the operation.

Complexity: Work assignment is unstructured, and leader is responsible for developing, directing, and managing outcomes and multi-year strategies to achieve the objectives of the operation. Duties performed include operational planning; developing standards, priorities, guidelines, processes, measurement (evaluation) systems; implementation of production and performance management standards; and allocating resources. Work is strategic and operational in nature.

Decision Making: Team member is responsible for managing multiple functions that requires developing and implementing strategies, business plans, and policies; determining required resources; defining and evaluating performance standards; and resolving complex business problems.

Communications: Communication at this level is internally and externally focused. Involves establishing and maintaining effective, collaborative working relationships with team members, peers, and executives. Provides information and negotiates solutions to functional issues that have major consequences or long-term significance.

Supervision Received: Responsible and accountable for driving strategy and achieving results for function(s). Work is reviewed for soundness of judgment and conclusions, fiscal accountability, and the attainment of goals and objectives of the operation.

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.