Director of Clinical Research
University of Chicago
Summary
The Director of Clinical Research in the Department of Medicine is responsible for leading the operations and conduct of clinical research across all general research sections within the department. This position will have primary accountability to the Executive Administrator within the Department of Medicine and secondary accountability to the Office of Clinical Research. The Director of Clinical Research in the Department of Medicine will partner with leaders within and outside of the department who are responsible for research compliance, regulatory affairs, research finance, human subjects protection, and clinical care to advance the research mission of UChicago Medicine.
Job description
Responsibilities
- Utilizes their deep subject matter expertise in clinical research regulations, research operations, people management, and project management to guide research teams and identify opportunities for department-wide clinical research excellence.
- Manage a team of Clinical Research Managers to lead the department’s human subject research portfolio and ensure high quality, standardized, and efficient clinical research operations.
- Participate in strategic decision making within the department as it relates to clinical research, guide staffing and resource allocation decisions, ensure timely and high quality clinical research services to faculty Investigators, evaluate staffing performance and quality, and advocate for clinical research staff to ensure an engaged and high functioning clinical research workforce.
- 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.
Minimum Qualifications
Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline. Certifications: ---
Preferred Qualifications
Education: Advanced degree. Experience: Supervisory skills. Background in a leadership role. Licenses and Certifications: Research certification, such as Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP.
Technical Skills or Knowledge
- Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy, such as site monitoring, quality assurance, and creating monitoring plans.
- Working knowledge of managing research projects.
- Develop research program and work strategically with principal investigator(s).
- Lead robust operational and financial analysis of study(ies) and/or program performance.
- Read and understand clinical trials protocols.
- Knowledge of regulatory policies and procedures.
- Knowledge of grant and contract administration.
- Familiarity with medical and scientific terminology.
- Demonstrated knowledge of Good Clinical Practices (GCP).
Preferred Competencies
- Develop a program and a team.
- Excellent time management skills and work independently.
- Strong analytical skills.
- Identify funding sources.
Requirements
- College or university degree in related field
- 7+ years of work experience in a related job discipline
- Advanced degree
- Supervisory skills
- Background in a leadership role
- Research certification, such as Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP
- Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy, such as site monitoring, quality assurance, and creating monitoring plans
- Working knowledge of managing research projects
- Develop research program and work strategically with principal investigator(s)
- Lead robust operational and financial analysis of study(ies) and/or program performance
- Read and understand clinical trials protocols
- Knowledge of regulatory policies and procedures
- Knowledge of grant and contract administration
- Familiarity with medical and scientific terminology
- Demonstrated knowledge of Good Clinical Practices (GCP)
- Develop a program and a team
- Excellent time management skills and work independently
- Strong analytical skills
- Identify funding sources
Benefits
- Health insurance
- Retirement plan
- Paid time off
Company overview
The University of Chicago is a world-renowned private research university founded in 1890 and located in Chicago's Hyde Park neighborhood. As a premier academic institution, it operates one of the most comprehensive biomedical research enterprises in the United States through its Biological Sciences Division, which includes over 1,100 faculty members across 10 basic science and 14 clinical departments. The university manages extensive research infrastructure including the University of Chicago Medicine Comprehensive Cancer Center, multiple specialized research institutes, and maintains affiliations with Argonne National Laboratory and Fermi National Accelerator Laboratory. With research funding exceeding $450 million annually and more than 3,300 patents filed since 1987, the institution is a global leader in scientific discovery and innovation. The Biological Sciences Division alone supports over 500 research-active faculty who secure an average of $588,000 in NIH funding per principal investigator, focusing on areas including cancer biology, immunology, microbiology, molecular metabolism, neuroscience, and evolutionary biology. The university's commitment to interdisciplinary research and its unique position as manager of national laboratories creates unparalleled opportunities for translational research and scientific advancement.