Associate Director of Research Compliance, OPHS

Associate Director of Research Compliance, OPHS

Hiring Department: Office of Population Health Sciences

Location: Chicago, IL USA

Requisition ID: 1025091

Posting Close Date: May 14, 2024

About the University of Illinois Chicago

UIC is among the nation's preeminent urban public research universities, a Carnegie RU/VH research institution, and the largest university in Chicago. UIC serves over 34,000 students, comprising one of the most diverse student bodies in the nation and is designated as a Minority Serving Institution (MSI), an Asian American and Native American Pacific Islander Serving Institution (AANAPSI) and a Hispanic Serving Institution (HSI). Through its 16 colleges, UIC produces nationally and internationally recognized multidisciplinary academic programs in concert with civic, corporate and community partners worldwide, including a full complement of health sciences colleges. By emphasizing cutting-edge and transformational research along with a commitment to the success of all students, UIC embodies the dynamic, vibrant and engaged urban university. Recent "Best Colleges" rankings published by U.S. News & World Report, found UIC climbed up in its rankings among top public schools in the nation and among all national universities. UIC has nearly 260,000 alumni, and is one of the largest employers in the city of Chicago.

Description:

Who We Are:

Housed within the Office of the Vice Chancellor for Health Affairs (OVCHA), the Office of Population Health Sciences (OPHS) at the University of Illinois Chicago conducts research to identify new tests and treatments for people with chronic lung disease, COVID-19, Long COVID, and other conditions. We also use healthcare delivery science to increase access to high-quality healthcare. Studies are conducted in collaboration with academic health centers, community-based organizations, and faith-based organizations in Chicago and other cities across the nation.

Job Summary:
The Associate Director of Research Compliance oversees all human subjects-related aspects of regulatory compliance for the Office of Population Health Sciences research portfolio, including clinical trials. This position works collaboratively with key compliance stakeholders across the University of Illinois System to ensure alignment of compliance activities. The Associate Director of Research Compliance is responsible for overseeing the development, implementation, and maintenance of effective methods to ensure compliance with federal, state, and institutional guidelines on the protection of human subjects. They oversee training development for IRB Coordinators and the Clinical Research team to provide oversight through close out. This includes education, process improvement projects, audits, investigations, research, and initiative support. This role will work closely with department PIs and Senior Leadership. The position serves as the department's primary contact with the Office of Research Services, external sponsors and internal/external auditors. They manage and supervise staff including IRB Coordinators and Clinical Research Coordinators.

Duties:

Research Compliance
• Manage operations related to research ethics related activities including preparation of IRB documents, reports, and materials.
• Oversee compliance monitoring of all human subject studies according to the protocols approved by the IRB and other research and campus oversight groups (federal, state, and institutional) for the Office of Population Health Sciences research portfolio.
• Investigate allegations and findings of non-compliance. Report potential serious or continuing non- compliance with applicable regulations or institutional policies.
• 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.
• Final review and approval of all completed applications, continuing reviews, protocol amendments, final reports, prompt reports, and/ or requests for exemptions in compliance with federal regulations, state laws and University policies and procedures for conducting research for IRB submission.
• Formulate plans for internal and external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities.
• Prepare audit reports detailing observations, regulatory risks, recommendations, corrective actions and any other actions necessary to bring human subjects research or IRB-approved activities into compliance for sponsors or other parties. Recommend action based on areas of concern identified during compliance reviews.
• Interact with investigators, research teams and research units to develop appropriate SOPs and quality improvement measures to ensure compliance with Good Clinical Practice guidance including obtaining and documenting consent, data security measures, subject recruitment and record keeping.
• Lead development, implementation, and quality improvement efforts of best practices for compliance and efficiency (e.g., create and maintain updated templates of forms; development of standardized text).
• Maintains subject-matter expertise on current, new or revised regulations and guidance issued by the Office for Human Subject Protections (OHRP), the State of Illinois, and other regulatory agencies.
• Educate and guide OPHS 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.
• Cooperate with UIC/UI Health and internal departments to ensure that health information is protected in accordance with HIPAA Federal regulations and University and sponsoring agency policies and procedures.

Communication

• Primary advisor in regulatory matters for OPHS Leadership and Principal Investigators.
• Primary contact with the Office of Research Services, UIC IRB for OPHS.
• Work collaboratively with key compliance stakeholders across the University of Illinois System to ensure alignment of compliance activities.
• Engage stakeholders, including research collaborators, other study team members, community advisory board members and participants to collect and communicate research requirements, and set expectations for research related work.

Staff management
• Oversee compliance orientation for new staff and training development for IRB Coordinators and Clinical Research team to provide oversight through close out, including: education, process improvement projects, audits, investigations, research, and initiative support.
• Work closely with staff to ensure effective implementation of study protocols, actively addressing issues with regulatory approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective.
• Model ethical conduct and encourages ethical behavior and business practices throughout the organization.
• Perform other related duties and participate in special projects as assigned.

Qualifications:

Minimum Qualifications:
• Master's degree in health science, social sciences or related field is required.
• 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 (IRB) 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.
• 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.

Preferred Qualifications:
• Experience in a university or healthcare environment
• Knowledge of clinical trials and IRB requirements

The University of Illinois System is an equal opportunity employer, including but not limited to disability and/or veteran status, and complies with all applicable state and federal employment mandates. Please visit Required Employment Notices and Posters to view our non-discrimination statement and find additional information about required background checks, sexual harassment/misconduct disclosures, and employment eligibility review through E-Verify.

The university provides accommodations to applicants and employees. Request an Accommodation

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