Biological Sciences Division at the University of Chicago · 20 hours ago
Director, Clinical Research Systems and Compliance
Chicago, IL
Full-time
Hybrid
Director/Executive
$120K/yr - $160K/yr
7+ years expThe Biological Sciences Division at the University of Chicago is seeking a Director for their Office of Clinical Research. This role manages multiple teams responsible for clinical research operations, ensuring compliance and effective integration of research systems across the institution.
Higher Education
Responsibilities
Act as business system owner for CTMS, OnCore, and the central intake system, ServiceNow. Responsibilities include but are not limited to driving continuous improvement through development of a multi-year roadmap and partnering with IT teams responsible for technical management
Provide strategic oversight and responsibility for the coverage-analysis service line, ensuring high-quality day-to-day operations, compliance with CMS requirements, ongoing process improvements, and sustainable growth of the unit
Oversee the central study intake platform and the staff responsible for intake operations, ensuring efficient study triage, accurate data capture, and alignment with enterprise research workflows
Manage the technology and education pillar for research systems, including the design of workflows, development of training materials, and delivery of ongoing education programs for OCR offices and end users. Develop and oversee a formalized CTMS training program for new and existing staff within the unit and affiliated partners
Lead, mentor, and develop a high-performing team of clinical research professionals, fostering a collaborative and innovative team culture
Provide operational guidance to internal teams and other institutional stakeholders to ensure alignment of operations and strategy
Develop and maintain Standard Operating Procedures and ensure adherence across the clinical research enterprise. Collaborate with institutional stakeholders to ensure compliance and optimization of processes
Employ data metrics to deliver insights and recommendations that inform strategic initiatives throughout the systems application lifecycle
Identify and implement best practices for clinical research workflows. Utilize process-improvement methodologies to enhance efficiency and effectiveness in study execution
Partner with finance, compliance, research administration, and other stakeholders to ensure seamless integration of clinical research activities as it relates to enterprise system optimization
Provide expert guidance on clinical research operations processes and serve as a resource for team members and collaborators across the institution
Monitor trends, changes, and new developments in federal, state, and local research regulations, laws, and guidance documents to ensure research operations and processes adhere to current requirements and industry best practices
Manages managers and professional staff to monitor financial transactions, revenues and expenditures for clinical research trials. Ensures all data is accurately recorded, utilizing institutional (accounting and research) policies
Monitors project management and ensures that clinical trials are conducted in compliance with federal and institutional regulations. Manages, monitors and reports project budgets and annual projections
Develops departmental plans, including strategic initiatives for the department, in collaboration with departmental and divisional leadership
Advises faculty and research staff on all facets of clinical trial research management, including research conduct and compliance
Performs other related work as needed
Qualification
Required
Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline
Act as business system owner for CTMS, OnCore, and the central intake system, ServiceNow
Provide strategic oversight and responsibility for the coverage-analysis service line, ensuring high-quality day-to-day operations, compliance with CMS requirements, ongoing process improvements, and sustainable growth of the unit
Oversee the central study intake platform and the staff responsible for intake operations, ensuring efficient study triage, accurate data capture, and alignment with enterprise research workflows
Manage the technology and education pillar for research systems, including the design of workflows, development of training materials, and delivery of ongoing education programs for OCR offices and end users
Lead, mentor, and develop a high-performing team of clinical research professionals, fostering a collaborative and innovative team culture
Provide operational guidance to internal teams and other institutional stakeholders to ensure alignment of operations and strategy
Develop and maintain Standard Operating Procedures and ensure adherence across the clinical research enterprise
Employ data metrics to deliver insights and recommendations that inform strategic initiatives throughout the systems application lifecycle
Identify and implement best practices for clinical research workflows
Partner with finance, compliance, research administration, and other stakeholders to ensure seamless integration of clinical research activities as it relates to enterprise system optimization
Provide expert guidance on clinical research operations processes and serve as a resource for team members and collaborators across the institution
Monitor trends, changes, and new developments in federal, state, and local research regulations, laws, and guidance documents to ensure research operations and processes adhere to current requirements and industry best practices
Manages managers and professional staff to monitor financial transactions, revenues and expenditures for clinical research trials
Monitors project management and ensures that clinical trials are conducted in compliance with federal and institutional regulations
Develops departmental plans, including strategic initiatives for the department, in collaboration with departmental and divisional leadership
Advises faculty and research staff on all facets of clinical trial research management, including research conduct and compliance
Preferred
Advanced degree in the sciences
Experience with Clinical Trial Management System (CTMS) and other enterprise solutions for research administration
Experience managing a team of individuals
Medicare Coverage Analysis knowledge and experience
Knowledge of policies, procedures and legislation concerning human subjects in research and the Code of Federal Regulations
Expert knowledge of ICH E6 Good Clinical Practices and regulations of clinical research set forth in the Code of Federal Regulations, the Office for Human Research Protections, Food and Drug Administration, National Institutes of Health and Center for Medicare and Medicaid Services or other relevant agencies
Ability to interpret research protocol information in relation to federal requirements and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies
Expert knowledge of CMS billing rules (NCD, LCD) and Medicare Coverage Analysis best practices
Experience leading highly functioning teams and overseeing managers and independent contributors
Proven record of building effective working relationships across functions as well as support effective partnerships with key groups and individuals
Expert knowledge of Microsoft Word, Excel, Outlook and PowerPoint software
Excellent organizational skills
Ability to work independently and drive work forward
Attention to detail
Ability to prepare accurate documentation and maintain confidential material and information
Excellent written and verbal communication skills to effectively interface with pharmaceutical industry, the hospital and departments within the Division
Ability to resolve issues, problem solve and make effective recommendations
Resume (required)
Cover Letter (preferred)
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
Company
Biological Sciences Division at the University of Chicago
As part of the University of Chicago, the Biological Sciences Division (BSD) pursues globally impactful solutions to seemingly unsolvable challenges.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase