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Senior Compliance Specialist - Chicago Illinois
Company: Regulatory Affairs Professionals Society Location: Chicago, Illinois
Posted On: 01/09/2025
Senior Compliance SpecialistJob ID: 50492Location: Chicago, IllinoisDepartment: Research IntegritySalary/Grade: EXS/10Job Summary:The Senior Compliance Specialist (SCS) supports ORI's mission by managing research misconduct and research non-compliance investigations to ensure efficient coordination of research-related reviews, University compliance with all applicable regulations and policies and correction of non-compliance, as appropriate. The work performed by the SCS involves highly confidential investigations of potential wrongdoings by faculty, staff and students. The SCS interacts with the highest levels of University administration, and coordinates closely with the Office of the General Counsel and federal regulatory oversight agencies. Outcomes of the SCS's work include: (1) comprehensive management of research non-compliance reviews; (2) federally compliant research misconduct proceedings; and (3) support and coordination of other ORI research compliance initiatives.The Senior Compliance Specialist will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.Specific Responsibilities: - Direct and conduct research misconduct investigations arising from allegations of wrongdoing, data falsification, fabrication or plagiarism, in accordance with federal regulations and institutional policy, including the management of faculty inquiry and investigation committee activities and reporting to federal oversight agencies. Perform forensic image analysis and data analysis using a variety of software including Photoshop, Excel, and PowerPoint, and create analytical tools for faculty committees. Draft reports for faculty committees in compliance with federal regulations and expectations.
- Lead focused reviews of potential research non-compliance, including coordination with other OR and central offices to ensure that research is consistent with federal, state, local and institutional requirements and implement corrective action plans as necessary.
- Work with ORI's Research training development processes as well as other OR and central offices to determine proactive approaches to prevent identified non-compliance issues from recurring.Minimum Qualifications:
- BA/BS or the equivalent in education & experience
- Five + years working experience in a higher education or business environment in a role related to audit, internal control, clinical research and/or investigative processesMinimum Competencies:
- Working knowledge of federal policies and regulations as they relate to research misconduct, research financial management, human subject protections and administration of sponsored projects and clinical research
- Strong knowledge of auditing techniques and possess the ability to understand and critically analyze research data, financial and other data, and documentation used in research to identify potential compliance risks
- Ability to understand and critically analyze various operational systems data and documentation to identify potential research compliance risks
- Self-motivation, preciseness in details and broad thinking
- Must possess effective project planning and project management skills with ability to meet deadlines and prioritize multiple tasks
- Strong communication skills, both verbal and written, and ability to interact with process owners and senior level management, faculty and staff across the University at a variety of levels and positions
- Demonstrated skills using computer applications for data retrieval and analysis
- Excellent problem-solving capabilities
- Work well independently as well as contribute to team effortsPreferred Qualifications:
- Doctor of Philosophy (Ph.D.) or Juris Doctorate (JD) degree
- Certified Fraud Examiner (CFE) designation or Certified Internal Auditor (CIA) designation
- A background in research compliance reviews, auditing, clinical trials monitoring or conducting human subject research.
- Experience with governmental report writing
- Experience with investigative, forensic and/or data science techniquesPreferred Competencies:
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