Research Compliance Analyst Sr

Position: Research Compliance Analyst Sr.
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 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H.

Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.
** Location
* * Simpson Querrey Biomedical Research Center
** Job Description
**** General

Summary:

**    ## ## Under the direction of the Director of Research Compliance within the Office of Research Integrity and Compliance (ORIC), the Senior Research Compliance Analyst supports daily operations and provides guidance and assistance to Stanley Manne Children’s Research Institute at Ann & Robert H. Lurie Children’s Hospital investigators and study teams requiring regulatory oversight for their research activities. This position works with a diverse portfolio of research sponsors and helps coordinate and maintain compliance in areas such as Conflicts of Interest (COI), Export Controls, research security and general research laboratory compliance.##

The Senior Research Compliance Analyst collaborates with various groups to facilitate regulatory compliance, including the Office of Sponsored Programs (OSP), principal investigators, hospital compliance, research fellows, regulatory coordinators, and external partners. The analyst provides operational and compliance support to these groups.##
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* Essential Job Functions:

*** Serves as a collaborative resource and consultant to Medical Center leadership, employees, medical staff, and others on research compliance topics and issues, including research security, conflicts of interest, export controls, and laboratory safety.
* Supports in the implementation and maintenance of programmatic activities, including, but not limited to, exclusion screening processes, the conflict of interest disclosure and review process, export control reviews, and the review and resolution of potential compliance issues.
* Assists with the development and updating policies and procedures to address areas of reputational, legal, regulatory, and other compliance risk affecting the Medical Center.
* Maintains a working knowledge of the healthcare enforcement environment and all applicable federal and state laws, statutes, and regulations, including those pertaining to research security, research compliance, and regulatory programs related to the research portfolio at the Medical Center.  Interprets applicable federal and state regulations in providing analysis and recommendations.
* Assists in responding to regulatory investigations, such as investigations conducted by the Department of Health and Human Services, Department of Justice, Bureau of Industry and Security, or Office of Foreign Assets Control.
* Contributes to the development of educational materials and resources to inform, educate, and train PI’s, ORIC staff, and other stakeholders about research compliance requirements.  May present at orientations and other venues.
* Responds to workforce inquiries and timely and appropriately notifies employees, leaders, and other stakeholders about compliance matters.
* Assists in the development and management of project plans and status reports for compliance initiatives.
* Conducts research and prepares reports regarding federal, state, and local laws and regulations as well as other compliance topics. Assists in the development and maintenance of compliance programs to ensure changes in regulatory and institutional requirements are integrated into draft policies.
* Maintains a personal presence characterized by honesty, integrity, and professionalism.
* Other duties as assigned.
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* Knowledge, Skills and Abilities:

*** Bachelor’s degree in a related field, or equivalent experience. (Postgraduate degree preferred but not required.)
* Minimum of 3 years substantive experience in research compliance or a regulated field, with at least 1 year of specialized experience in export controls, conflict of interest (COI), or research…