The University of Illinois Chicago is accepting applications for a director in our newly created area of Clinical Research Compliance. Working in the Office of the Vice Chancellor for Research (OVCR) and reporting to the Associate Vice Chancellor for Research, this position oversees a team of research compliance specialists and ensures all research programs and other academic activities that involve human subjects and research activities are in full compliance with UIC regulations, and local, state, and Federal laws, rules or regulations governing research with human subjects. Responsible for the continued development and implementation of a post-IRB approval monitoring program of research studies involving human subjects, as well as other quality improvement activities.
Develop and implement policies for clinical research compliance oversight in collaboration with the Vice Chancellor for Research (VCR), Associate Vice Chancellors for Research (AVCR), and other OVCR Directors.
Perform and supervise staff conducting routine and as needed compliance monitoring of all human subject studies according to the protocols approved by the IRB and other research and campus oversight groups. The Director will both conduct reviews and will supervise compliance specialists conducting reviews.
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.
Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance with applicable regulations or institutional policies to OVCR leaders as appropriate.
Interview human subjects study personnel and review records to identify possible areas of concern so that any issues can be proactively addressed.
Coordinate and facilitate cooperation between the OVCR, UI Health System and University IT and compliance offices to ensure that health information is protected in accordance with HIPAA Federal regulations and University and sponsoring agency policies and procedures.
Coordinate and facilitate review of research with UIC administrators, federal agency representatives, and/or study sponsors when necessary, including, but not limited to, the Office for Human Subject Protections (OHRP).
Provide Investigators with quality improvement recommendations and facilitate engagement of technical assistance to ensure that research is conducted in compliance with regulations and approved protocols.
Assist investigators and the institution in preparations for internal and external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities.
Assist in the development of corrective actions and written responses as warranted.
Prepare written reports detailing observations, regulatory risks, recommendations, and any other actions necessary to bring human subjects research or IRB-approved activities into compliance. Recommend action to the VCR and AVCRs based on areas of concern identified during compliance reviews.
Perform other related duties and participate in special projects as assigned by the AVCR.
A Master’s degree in biomedical, health science, social sciences or related field is required, Doctoral degree preferred.
ACRP (Association of Clinical Research Professionals) certification strongly preferred.
A minimum of 5 years of experience in monitoring and oversight of human subjects protections, research compliance oversight and/or clinical trials or research administration.
Prior experience with Institutional Review Board application materials and processing.
Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects, such as the Office for Human Research Protection (OHRP).
Ability to understand, interpret, and apply complex federal, state, university, and accreditation regulations pertaining to research involving human subjects.
Experience building a team and/or supervising clinical research or compliance staff.
Strong documentation and communication skills, including the ability to provide clear guidance and instruction to staff.
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 December 6, 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:
As an EOE/AA employer, the University of Illinois will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, gender identity, sexual orientation, national origin, and Veteran or disability status.
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. For more information, visit: https://www.hr.uillinois.edu/cms/One.aspx?portalId=4292&pageId=1411899
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.