Senior Regulatory Affairs Specialist, Operations

3 weeks ago

Chicago, Illinois, United States Northwestern University Full time

Job Summary:

The Senior Compliance Specialist supports Northwestern University'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 Senior Compliance Specialist involves highly confidential investigations of potential wrongdoings by faculty, staff, and students.

The Senior Compliance Specialist interacts with the highest levels of University administration, and coordinates closely with the Office of the General Counsel and federal regulatory oversight agencies.

The Senior Compliance Specialist will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.

Key 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.

Requirements:

  • Five + years working experience in a higher education or business environment in a role related to audit, internal control, clinical research, and/or investigative processes.
  • 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 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.
  • Must possess effective project planning and project management skills with the ability to meet deadlines and prioritize multiple tasks.
  • Strong communication skills, both verbal and written, and the 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.
  • 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 techniques.
  • Knowledge of the federal research misconduct policies and procedures.

Benefits:

Northwestern University offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.

We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care.

Northwestern strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness.

More information can be found on the COVID-19 and Campus Updates webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami, and Ho-Chunk nations.

Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply.

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