The University of Illinois at Chicago is seeking applicants for the role of Clinical Research Compliance Specialist in our Office of the Vice Chancellor for Research. The role reviews UIC’s compliance with regulations governing research and other activities that involve human participants and ensures research activities are in full compliance with local, state, or Federal laws, rules or regulations that impact research with human subjects.
Perform routine compliance reviews of human subjects studies and IRB activities. Conduct reviews at the request of the Associate Vice Chancellor for Research (AVCR) and/or the Director of OPRS.
Coordinate with the Office of Protection for Research Subjects (OPRS) to facilitate cooperation and health system and University compliance offices to ensure that health information is protected in accordance with HIPAA Federal regulations and University and sponsoring agency policies and procedures.
Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance with applicable regulations or institutional policies to the AVCR and other leaders as appropriate. Provide Principal Investigators with quality improvement recommendations to ensure that research is conducted in compliance with regulations and approved protocols.
Educate and guide researchers, faculty, staff, and students in the design and conduct of human subject research to ensure compliance with federal and state regulations and UIC policy.
Interact when necessary to facilitate the review of research with UIC administrators and federal agency representatives, including, but not limited to, the Office for Human Subject Protections (OHRP).
Maintain IRB-required record keeping and prepare correspondence to UIC investigators, study sponsors, and regulatory agencies that document the determinations of the IRB.
Prepare written reports detailing observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance. Recommend action to the AVCR based on areas of concern identified during compliance reviews.
Assist investigators and the institution in preparations for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities. Provide education on expectations and how best to prepare and organize materials and interact with the auditors or inspectors. Interview personnel and review records in advance to identify possible areas of concern so that the issues can be proactively addressed. Provide support and guidance to exit interviews at the request of the Director. Assist in the development of corrective actions and written responses as warranted.
Perform other related duties and participate in special projects as assigned.
Bachelor's degree in biomedical, health science, social sciences or related field is required.
Certification in Healthcare Research Compliance, as a Clinical Research Professional, and/or as a Certified IRB Professional preferred.
A minimum of 3-5 years of experience in the monitoring and oversight of human subjects protections or 3-5 years experience in research compliance oversight and/or research.
Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects, including 45 CFR 46 and 21 CFR 50, 56, 312 and 812.
Ability to understand, interpret, and apply complex federal, state, university, and accreditation regulations pertaining to research involving human subjects. Strong documentation and communication skills, including the ability to provide clear guidance and instruction.
Demonstrated analytical skills to gather, interpret, organize and present compliance-related data.
Demonstrated success working collaboratively with interdisciplinary teams of external and internal individuals.
Well organized, high energy, effective at multi-tasking, self-motivated. Strong interpersonal and communication skills.
Knowledge of basic information systems (Word, Excel, Adobe, and other database applications).
APPLICATION: To ensure fullest consideration, application materials must be received by June 18, 2021. Start date is as soon as possible after the close of the search. Salary is commensurate with experience and education. All candidates must create a candidate profile through http://jobs.uic.edu and upload a cover letter, resume and contact information for three references by the close date.
Candidates must apply for this role by visiting the following link:
The University of Illinois at Chicago is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.
Offers of employment by the University of Illinois may be subject to approval by the University’s Board of Trustees and are made contingent upon the candidate’s successful completion of any criminal background checks and other pre-employment assessments that may be required for the position being offered. Additional information regarding such pre-employment checks and assessments may be provided as applicable during the hiring process.
The University of Illinois System requires candidates selected for hire to disclose any documented finding of sexual misconduct or sexual harassment and to authorize inquiries to current and former employers regarding findings of sexual misconduct or sexual harassment.
The University of Illinois Chicago is the city’s largest university and its only public Carnegie Research 1 institution. Its 16 academic colleges serve more than 33,000 undergraduate, graduate and professional students. UIC is recognized as one of the best public universities and one of the most ethnically rich and culturally diverse campuses in the nation, located in the heart of Chicago, it is an integral part of the educational, technological and cultural fabric of one of the world’s greatest cities.