GENERAL SUMMARY:

The Research Compliance Officer, as supported through the Shirley Ryan AbilityLab Compliance Program and Office General Counsel, will oversee and conduct research compliance activities and advise on research matters including clinical trials, sponsored projects, human research protections, and related matters such as conflict of interest and clinical trial billing. The Research Compliance Officer will:

• be an integral part of the Enterprise Risk Management Program, including the Compliance Program;
• collaborate with SRAlab researchers to create and deliver compliance education and best practices for human subject research based upon SRAlab’s environment and Vision;
• collaborate with the SRAlab’s Office of Research Administration and clinicians/researchers engaged in human subject research to provide guidance on regulatory matters;
• assist, partner, and develop consistent practices with the Northwestern University Institutional Review Board, SRAlab IRB of Record; and
• collaborate with the Office of General Counsel for assistance in interpreting regulatory requirements and/or legal advice on issues, concerns, and/or risks.

The Research Compliance Officer will consistently demonstrate support of the Shirley Ryan AbilityLab statement of Vision, Mission and Core Values by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the institute.

The Research Compliance Officer will demonstrate Shirley Ryan AbilityLab Core Attributes: Communication, Accountability, Flexibility/Adaptability, Judgment/Problem Solving, Customer Service and Values (Hope, Compassion, Discovery, Collaboration, & Commitment to Excellence) while fulfilling job duties.

PRINCIPAL RESPONSIBILITIES:

THE RESEARCH COMPLIANCE OFFICER WILL:

1. Serve as subject matter expert for day-to-day research compliance questions and advise on a wide variety of research compliance matters
2. Serve as SRAlab’s OHRP Human Protections Administrator.
3. In collaboration with the Office of General Counsel, coordinate, draft, and oversee regulatory submissions and reporting activities, and work with regulators and others to clarify and resolve issues.
4. In collaboration with the Office of General Counsel, develop and lead educational and training programs designed to provide employees, students, medical staff members, relevant contractors, researchers, and volunteers with knowledge of, and the guidance to comply with, laws, rules, regulations, and policies related to or impacting research.
5. Monitor the healthcare regulatory environment for emerging trends and assist stakeholders assess any impact to the SRAlab and research function. Assist with the development of comments to government agencies and other relevant parties.
6. Research and recommend actions to be taken (after consulting, as appropriate, with the Office of General Counsel) and assist in the interpretation of new or revised regulatory requirements.
7. Identify potential compliance external forces and internal vulnerabilities  impacting research at SRAlab and determine the level of risk; recommend remediation, including an assessment of internal controls, and lead or co-lead systemic process improvements.
8. With the Office of Research Administration, monitor, revise, and develop research policies and procedures and the Research Compliance Handbook. Provide expertise for other policies and procedures that impact or are affected by research.
9. Develop, recommend, and conduct audits to test compliance with laws, rules, regulations, and policies.
10. Monitor the implementation of corrective action plans and/or process improvements resulting from internal or external reviews.
11. Investigate and oversee resolution of compliance-related complaints and hotline calls and work closely with the Chief Integrity Officer, the Office of General Counsel, and the Office of Research Administration to resolve the complaints and implement remediation plans as appropriate.
12. Coordinate research and non-research related conflict of interest matters.
13. Assist in the creation and monitoring of conflict of interest management plans.
14. Lead or participate on various ad hoc and standing hospital and research committees. With the Chief Integrity Officer, represent SRAlab on the Northwestern University IRB Advisory Committee.
15. With the Compliance team, promote the visibility of the Enterprise Risk Management Program including the Compliance Program.
16. Other duties and projects as assigned by the Chief Integrity Officer.
17. Perform all other duties that may be assigned in the best interest of SRAlab

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REPORTING RELATIONSHIP:

Reports directly to the Chief Integrity Officer

KNOWLEDGE, SKILLS & ABILITIES REQUIRED:

1. Bachelor's degree required.
2. Master's Degree in a related field or other advanced degree or significant research compliance experience strongly preferred.
3. Strong working knowledge of and experience with the research regulatory environment and regulatory framework governing human subject research, conflicts of interest, research misconduct, and the responsible conduct of research.
4. Minimum of 5 years research and/or compliance related experience required.
5. Experience with the conduct and administration of clinical trials and sponsored projects administration required, preferably with an academic medical center.
6. Demonstrated ability to effectively interface with Principal Investigators and research and medical center staff.
7. Certified in Healthcare Research Compliance (CHRC) and/or Certified IRB Professional (CIP) a plus.

 WORKING CONDITIONS:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

 SRAlab is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Required Skills Required Experience