Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
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Director, Research Compliance
Ann & Robert H. Lurie Children's Hospital of Chicago
Application
Details
Posted: 29-Mar-24
Location: Chicago, Illinois
Type: Full Time
Categories:
Quality/Risk Management
Sector:
Hospital, Public and Private
Additional Information:
Telecommuting is allowed.
Internal Number: JR2024-968
The Director, Research Compliance assumes a critical role in the research enterprise at Stanley Manne Children’s Research Institute and provides operational and administrative oversight of several components of the Lurie Children’s Research Compliance Program within the Office of Research Integrity & Compliance. This highly collaborative position is responsible for providing oversight, support, and cooperative leadership in coordination with the Research Compliance Officer for one or more areas of the Research Compliance Program. This may include Conflicts of Interest, Financial Compliance, Export Controls, Foreign Influence, Data and Information Security, or other areas as assigned. The Director, Research Compliance participates in and is responsible for the long-term planning, development, and implementation of the Research Compliance Program.
Essential Job Functions:
General Duties
Collaborate with groups in Research Administration, Compliance, and other institutional functions, including Privacy and Legal Services.
Oversee day-to-day operations of specific areas within the Research Compliance program.
Manage a diverse staff and ensure employees work productively and develop professionally within an atmosphere of learning and engagement.
Oversee staff recruitment, hiring, training, and performance evaluation.
Prepare reports related to research compliance activities and outcomes.
Conflicts of Interest
Enhances and maintains the Research Conflict of Interest Program in coordination with the Research Compliance Officer, Research Innovation Office, Corporate Compliance, and other Key Stakeholders.
Responsible for the review and management of faculty, research staff, and institutional outside relationships that are related to research to ensure compliance with sponsor requirements, regulations, and institutional policies for conflicts of interest and commitment.
Frequently interacts with faculty and research scientists to provide consultation and guidance on the policies relating to conflicts of interest and commitment in research identifies issues and risks for consideration for the Conflict-of-Interest decisionmakers and the Institutional Conflict of Interest Committee.
Responsible for the development, implementation, and maintenance of the Lurie Children’s Research Conflict of Interest Program, including, but not limited to, creation of forms, policies, and educational resources; mentorship; and monitoring of Conflict Management Plans.
Financial Compliance
Responsible for leading and directing the research financial compliance functions of the Research Compliance Office.
Develops the Research Financial Compliance Monitoring Program in cooperation with leadership from the Office of Sponsored Programs, Office of Research Finance, Office of Clinical and Community Trials, Basic Sciences, and other key stakeholders to ensure compliant research financial operations.
Provides guidance and direction for quality assurance, quality improvement, and education pursuant to research financial/billing compliance.
Develops and completes compliance work plans, audits, and projects and reports conclusions and recommendations to ensure an effective, efficient, and objective approach for evaluating and improving activities of the Stanley Manne Children’s Research Institute.
Export Controls and Foreign Influence
Maintains enhancement and ongoing evaluation of the Export Compliance and Management Program (ECMP) in coordination with the Research Compliance Officer and Hospital Information Management to ensure compliance with applicable laws, rules, and regulations.
Serves as a resource to faculty, staff, and leadership to assist in determining whether a person, entity, or item related to research is subject to export controls.
Reviews and screens research grants and contracts to facilitate research sponsored portfolio compliance with all applicable US export and sanctions regulations, including, but not limited to, denied party, end-use, end-user, and embargo screening; anti-boycott, commodity jurisdiction, classification and export determination; licensing determination and implementation; and export and re-export laws and regulations.
Enhances and maintains the Foreign Influence Monitoring Program to identify and evaluate categories of federal grants for potential factors contributing to higher levels of risk to foreign influence and review grants for compliance with requirements associated with foreign influence risk.
Provides guidance related to travel restrictions relating to the export control regulations, such as traveling with devices (laptops, cell phones, etc.) in coordination with Hospital Information Management, Corporate Compliance, and Legal Services. Conducts reviews of all international travel proposed in research to ensure compliance with regulations.
Facilitates the preparation, monitoring, and auditing of Technology Control Plans and License applications in coordination with Hospital Information Management.
Oversees and implements education and training through the creation and delivery of training materials, presentations, policy development, and standard operating procedures.
Data and Information Security
Enhances and maintains the Research Data Monitoring Program in coordination with the Data Discovery and Development Team in Quantitative Sciences.
Implements research data security policies, procedures, and monitoring for compliance with requirements associated with Federal Contract Information (FCI), Controlled Unclassified Information (CUI), Protected Health Information (PHI), Health Insurance Portability and Accountability Act of 1996 (HIPAA), Family Educational Rights and Privacy Act (FERPA), Personally Identifiable Information (PII), General Data Protection Regulation (GDPR), and NSPM-33, among others.
Serves as a resource for researchers in the handling of research data, confidential information, proprietary materials, as well as the selection and use of repositories for the curation of research datasets.
Oversees and implements education and training through the creation and delivery of training materials, presentations, policy development, and standard operating procedures.
Bachelor’s degree in related field required. Master’s degree preferred.
Certification in Export Controls required within one year of hire.
8 or more years of progressive experience in research compliance within one or more applicable areas.
Experience growing compliance programs or leading/supporting organizational change.
Significant experience in managing a diverse staff.
Interpersonal skills necessary to interact effectively with physicians, principal investigators, medical center personnel, and external funding agencies and to maintain a variety of internal and external contacts.
Must possess strong written and verbal communication skills and be detailed oriented.
Demonstrated ability to work constructively, collaboratively, and diplomatically with many diverse individuals and groups within and outside the organization.
Ability to communicate with all levels of faculty and staff within the institution in an accurate, helpful, and customer service-oriented manner.
Ability to be flexible, effectively prioritize tasks, exercise good judgement, and be decisive under pressure, including in stressful situations and under deadlines.
Excellent command of the English language; knowledge of medical terminology is required.
Organizational skills, including the ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations. Ability to work effectively under pressures of various deadlines.
Candidate must be able to make independent decisions and function independently with minimal supervision. Candidate should be able to function with a high level of discretion and confidentiality.
Must maintain current knowledge of federal, state, and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP, FDA, OLAW, and USDA.
Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
Certified, or willing to become certified, in an export compliance program certification to demonstrate working knowledge of the EAR, OFAC, and ITAR and other applicable export control regulations.
About Ann & Robert H. Lurie Children's Hospital of Chicago
Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 138-year legacy of excellence, kids and their families are at the center of all we do. Lurie Children's has been named one of America's best midsize employers by Forbes, is ranked by the U.S. News and World Report in 10 specialties, and is the only pediatric hospital in Illinois to have earned it's fifth Magnet designation.
Stanley Manne Children's Research Institute, affiliated with Lurie Children's, is devoted to the understanding, prevention and investigation of pediatric illnesses and injuries. All pediatric research at Lurie Children’s is conducted through the Stanley Manne Children’s Research Institute. It has been designated a Northwestern University Feinberg School of Medicine research center for its central role in the university’s integrated research program. Established in 1986, our pediatric research institute has more than 200 investigators, 500 staff members and 100 trainees who contribute to six growing pr...ograms in basic research and translational medicine at the research facility. We also have interdisciplinary centers of excellence that target specific child health issues and complement our core programs.
Promoting the health and well-being of children and adolescents beyond the hospital walls is a critical part of our mission. All community-focused initiatives at Lurie Children’s are led by the Patrick M. Magoon Institute for Healthy Communities. The Magoon Institute builds strong collaborations with community organizations to reach youth where they live, learn and play and help them thrive. One of its top priorities is to address the root causes of health disparities, including racism, poverty, poor access to healthcare, housing insecurity, food insecurity, unemployment, violence, and an unsafe physical environment. The Magoon Institute also facilitates community-engaged outreach and research initiatives to advance and implement evidence-informed child and adolescent health programs and practices.
Lurie Children’s relies on philanthropic funding to enhance its programs and services for children and families. Founded in 1987, the Ann & Robert H. Lurie Children’s Hospital of Chicago Foundation is a charitable 501(c)(3) tax-exempt organization with fundraising professionals who work with 11 affiliated organizations and an active team of volunteers to cultivate and secure contributions that advance the mission of the hospital. In 1994, Lurie Children's established the Public Policy Committee of the Board to recommend institutional positions on legislation and regulation that enable the hospital to enhance the health and well-being of all children.