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Research Compliance Officer - Office General Counsel, Full-time in Chicago, IL at Shirley Ryan Abilitylab

Date Posted: 6/27/2018

Job Snapshot

Job Description

General Summary

The Research Compliance Officer will focus on overseeing compliance activities related to research and advise on matters related to clinical trials, sponsored projects, human research protections, conflict of interest and clinical trial billing. The Research Compliance Officer will also assist in the administration of the Corporate Compliance Program and HIPAA Privacy Office.

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 RIC Core Attributes: Communication, Accountability, Flexibility/Adaptability, Judgment/Problem Solving, Customer Service and RIC 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 compliance questions and advise on a wide variety of compliance matters. Research and recommend actions to be taken after consulting, as appropriate, with the Office of General Counsel.
  2. Assist in the interpretation of new or revised regulatory requirements and develop policies and procedures, as needed
  3. Coordinate research and non-research related conflict of interest matters; manage conflict of interest management plans, as needed.
  4. Develop, recommend and conduct audits to test compliance with established laws, rules, regulations and policies.
  5. Investigate and oversee resolution of compliance-related complaints and hotline calls.
  6. Develop and lead educational and training programs to help ensure employees, students, medical staff members, applicable contractors, researchers and volunteers, have knowledge of, and comply with, pertinent laws, rules, regulations and policies, as applicable.
  7. Monitor the healthcare regulatory environment for emerging trends and assist stakeholders in assessing any impact to the hospital and research function and commenting to government agencies and other applicable parties.
  8. Identify potential compliance vulnerability external to and within SRAlab and determine the level of risk; recommend remediation, including an assessment of internal controls, as applicable.
  9. Monitor the implementation of corrective action plans and/or process improvements resulting from internal or external reviews.
  10. Coordinate and oversee regulatory submissions and reporting activities, including working with regulators and others to clarify and resolve issues.
  11. Assist in managing and expanding the visibility of the Corporate Compliance Program, including but not limited to, the HIPAA Privacy Office.
  12. Lead or participate on various ad hoc and standing hospital and Research committees. Represent SRAlab on the Northwestern University IRB Advisory Committee.
  13. Serve as SRAlab’s OHRP Human Protections Administrator
  14. Frequently interact with the Office of General Counsel for assistance in interpretation of regulatory requirements and/or legal advice on issues, concerns and/or risks.
  15. Frequently interact and partner with the Internal Audit Department on reviewing and/or assessing potential or actual risks, conducting audits and/or other projects.
  16. Frequently interact with the Office of Research Administration and the Advanced Center for Clinical Research to provide guidance on regulatory matters in sponsored projects administration and the conduct and administration of clinical trials, respectively.
  17. Other duties and projects as assigned by the Corporate Compliance & Privacy Officer.
  18. Perform all other duties that may be assigned in the best interest of SRAlab.

Reporting Relationships

Reports directly to the Corporate Compliance Officer

Job Requirements

  1. Bachelor's degree required.
  2. Master's Degree in a related field or other advanced degree or significant compliance experience preferred.
  3. Minimum of 5 years research compliance related experience required.
  4. Experience with or knowledge of conduct and administration of clinical trials and sponsored projects administration preferred.
  5. Demonstrated ability to effectively interface with Principal Investigators, research and hospital staff.
  6. Certification in Healthcare Research Compliance (CHRC) and/or Institutional Review Board (CIRB) preferred.

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.

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