The Director for the Office of Research Integrity & Compliance (ORIC) will provide leadership for the entire research compliance enterprise within the Manne Research Institute. The Director is responsible for achieving strategic research goals, cultivating a collaborative and comprehensive research compliance infrastructure, and promoting integrity and compliance with applicable federal and state laws and research regulations, professional and ethical standards, and institutional policies and procedures throughout the research enterprise. The Director oversees and coordinates all areas Office of Research Integrity & Compliance (ORIC) including the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), the Quality Assurance/Quality Improvement (QA/QI), Clinical & Behavioral Research Education, Conflict of Interest, and Responsible Conduct of Research programs and staff. The Director provides guidance and high-level support to the researchers and research staff throughout the Institution, as well as senior leadership. The Director fosters a climate of transparency, openness, operational excellence, and mutual respect while delivering measurable results in a fiscally accountable manne
1. Assists senior research leadership in defining organizational goals and developing strategic plans for continued growth and advancement of research enterprise; makes tactical decisions related to overarching research compliance program.
2. Ensures the rights, welfare, and well-being of human subjects involved in research are protected.
3. Maintains current knowledge of pertinent laws and regulatory requirements.
4. Develops policies and procedures to:
a. promote the responsible conduct of research that is fully compliant with applicable regulations (local policies, laws, federal regulations, etc.)
b. improve the safe and efficient conduct of research
c. reduce administrative burden and improve operational efficiency
d. accelerate protocol review and decision turnaround times.
5. Oversees the membership and operations of essential research compliance committees (Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), etc.) and ensures they meet or exceed minimal requirements/maintains membership appointments/rosters; monitors performance. Assists in recruiting and evaluating members of the Research Compliance Committees. Provides guidance and high-level support to the IRB and IBC chairs and members.
6. Oversees the recruitment, training, management and activities of the ORIC staff: Associate Directors, Assistant Director of Research Education, the Research Compliance Coordinators, the QA/QI Specialists, and the Research Educators.
7. Serves as the primary liaison for research compliance between other areas of Manne Research Institute Research Administration, Lurie Children’s Privacy and Security Officers, the Office of General Counsel, Corporate Compliance, and other offices within Lurie Children’s, as needed.
8. Disseminates information throughout the organization to ensure the Institution is aware of research integrity and compliance issues;
9. Submits annual report on possible research misconduct to Department of Health and Human Services
(HHS) Public Health Service (PHS) Office of Research Integrity (ORI).
10. Updates/maintains IRB registration with Office of Human Research Protection (OHRP): The Institutional Federalwide Assurance for the Protection of Human Subjects (FWA) and IRB Organization (IORG).
11. Supports activities of the Institutional Biosafety Committee (IBC) and submits annual IBC registration and assurance report to the Office of Biotechnology Activities (IBC).
12. Addresses concerns/complaints from research participants or others (internal/external).
13. Plays key role in audits by external regulatory agencies (i.e., FDA, OHRP, etc.), the evaluation of allegations of serious/continuing noncompliance and/or scientific misconduct, the development of robust corrective and preventive action plans (CAPA), and the reporting to regulatory authorities. Drafts reports to applicable regulatory authorities (i.e., Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), etc.) when serious or continuing non-compliance and/or unanticipated problems have been identified. Responds to inquiries from these or other regulatory bodies (i.e., both routine and for cause audits).
14. Manages sensitive investigations of allegations of misconduct or suspected non-compliance. Informs leadership, the compliance committees and applicable regulatory authorities as required by the criteria as set forth by federal regulations and/or institutional policies, OHRP, FDA, and ORI. Responds to inquiries regulatory authorities (i.e., both routine and for cause audits).
15. Ensures standards for AAHRPP Accreditation are maintained, submits annual progress reports, and applications for re-accreditation.
16. Participates in various hospital committees relating to research operations to ensure compliance.
17. Oversees the protection of research participant data to ensure HIPAA authorization is obtained, criteria for waivers have been met, and/or proper agreements (Business Associate, Data Use, and Material Transfer) have been executed as applicable
18. Leads review of investigator disclosures of significant financial interests and develops management plans for those that pose potential conflicts of interest with research or sponsored programs. Ensure the IRB reviews those related to human subjects’ research projects.
19. Oversees the facilitation of collaborative research efforts and IRB Authorization Agreements.
20. Accountable for financial management within areas of responsibility.
21. Creates and environment of transparency and trust.
22. Dedicated to professional growth and seeks opportunities to enhance professional advancement.
1. Advanced degree in related field required (healthcare administration, clinical research, research administration, business, etc.); expert/comprehensive knoweldge of all functional areas of research compliance.
2. A minimum of eight years of clinical research/research compliance experience with at least five years management responsibility. Highly experienced program development and problem-solving techniques.
3. Certification IRB Professional (CIP) or comparable certification required (CRA, CCRC, CCRP, CHRC, etc.) to demonstrated advanced knowledge of federal and state regulations related to governmental research compliance, conflict of interest, and other institutional regulations and/or policies related to research integrity.
4. Progressive relevant experience in overseeing regulatory committee operations with experience working in an academic medical center IRB office strongly desired. Experienced and proficient in balancing regulatory compliance requirements against practical needs and limitations.
5. Experience with the AAHRPP accreditation process.
6. Demonstrated skill in developing and managing strategic initiatives, formulating policy recommendations, and addressing issues raised in either internal or external reviews, inspections, and/or audits
7. Competent in strategic thinking, interpersonal/interdisciplinary communication, group process, facilitation, negotiation and conflict resolution.
8. Excellent written and oral communication skills to develop high level strategic planning documents, reports, position papers and deliver oral presentations that effectively communicate needs and engage stakeholders regarding research compliance initiatives and priorities.
9. Ability to network and interact, as well as support effective partnerships with key groups and individuals. Demonstrated ability to manage relationships with faculty, investigators, senior-level management, staff, colleagues as well as locoal, state and federal regulatory agencies.
10. Provides leadership to others in a collaborative and facilitative style within a matrix reporting structure as well as a complex organizational setting.
11. Demonstrates and sets high standards of behavior, performance, quality, credibility, and integrity. Exhibits judgment and business acumen necessary to effectively advocate for institutional research compliance.