Visiting Clinical Research Compliance Coordinator

Description : Who We Are

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.

Position Summary

The Office of Population Health Sciences (OPHS) at UIC is seeking applications for a Visiting Clinical Research Compliance Coordinator.

This role is a key team member in OPHS for the Human Subject Research Compliance aspect of the department. This position supports the Associate and Assistant Director(s) of Research Compliance to ensure all 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.

The coordinator will assist in the drafting of IRB submissions, development and implementation of standard operating procedures to monitor studies involving human subjects, assist in oversight and internal audits of studies for the department, education for research investigators and study staff , as well as other quality improvement activities.

Duties & Responsibilities

Conduct 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.

Coordinate internal-audits of existing clinical research studies. Present progress, findings, and corrective action plans to Directors.

• Lead the documentation of Note To Files, Reportable New Information, continuing reviews, and amendments under director’s guidance in collaboration with the project managers / Sr research coordinators.
• Developing standard operating procedures and training programs for coordinators, under Directors guidance. Prepare IRB submissions for large, multisite observational studies, Organize and maintain regulatory materials.

Educate and guide OPHS Clinical Research Team in the design and conduct of human subject research to ensure compliance with federal and state regulations and UIC policy.

Assist the Directors to Investigate allegations and findings of non-compliance. Report potential serious or continuing non- compliance with applicable regulations or institutional policies to director.

Interview human subjects study personnel and review records to identify possible areas of concern so that any issues can be proactively addressed.

• Cooperation between the OPHS, 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.
• Make recommendations for quality improvement 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.
• Perform other related duties and participate inspecial projects as assigned

Qualifications :

Minimum Qualifications

• Bachelor’s degree in biomedical, health science, social sciences or related fields 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.
• 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.
• Well organized, high energy, effective at multitasking, self-motivated. Strong interpersonal and communication skills.
• Knowledge of basic information systems (Word, Excel, Adobe, and other database applications).

Preferred Qualifications

• Masters Degree in relevant field preferred.
• ACRP (Association of Clinical Research Professionals) certification preferred.
• HCCA (HealthCare Compliance Association) certification preferred.
6 days ago