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BSD OCR - Clinical Research Operational Excellence

About the Department

The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. The OCR focuses on six key areas of service including: Human Subject Protection (IRB); Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure.

Job Summary

The Associate Director, Clinical Research Operations is responsible for developing and overseeing a high-performing team of clinical research professionals. The Associate Director, Clinical Research Operations utilizes their deep subject matter expertise in clinical research regulations, research operations, and the commercialization process to guide research teams and identify opportunities for division-wide operational systems and process improvement. With minimal guidance, the Associate Director, Clinical Research Operations oversees the design, implementation, and management of standardized OnCore calendars and a comprehensive, central process for national coverage analysis of clinical research studies and work closely with stakeholders across the division, including finance, compliance, and research administration, to ensure seamless integration of clinical research activities with clinical research systems and processes.

Responsibilities

• Lead, mentor, and develop a high-performing team of clinical research professionals. Foster a collaborative and innovative team culture.
• Act as business system owner for clinical trial management system (CTMS), research module of electronic health record, and other systems utilized to support research activities. Responsibilities include but are not limited to driving continuous improvement (development of roadmap) from the business perspective, development and maintenance of training materials in collaboration with information technology teams responsible for system management.
• Oversee the design, implementation, and management of standardized OnCore calendars and a comprehensive, central process for national coverage analysis of clinical research studies.
• Develop Standard Operating Procedures and ensures they are adhered to within the system. Collaborate with stakeholders to ensure compliance and optimization or process across the clinical research enterprise.
• Employs data metrics to deliver insights and suggestions that inform strategic initiatives throughout the entire systems application lifecycle.
• Identify and implement best practices for clinical research workflows. Utilize process improvement methodologies to enhance efficiency and effectiveness in study execution.
• Actively participate in the development and execution of strategic initiatives that advance the goals of the clinical research enterprise. Collaborate with leadership to align projects with institutional priorities.
• Work closely with stakeholders across the division, including finance, compliance, and research administration, to ensure seamless integration of clinical research activities.
• Provide expert guidance on clinical research operations processes. Act as a resource for team members and collaborators.
• 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 bes practices.
• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Advanced college or university degree in related field, strongly preferred.

Experience:

• Knowledge and skills developed through 5-7 years of work experience in a related job discipline, strongly preferred.

Preferred Competencies