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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400048 Medicine M&D-Infect Dis Unit

Work Shift:

UR - Day (United States of America)

Range:

UR URG 114

Compensation Range:

$86,900.00 - $130,300.00

Responsibilities:

Provides operational leadership, oversight, and standardization of clinical research activities across the Department of Medicine Clinical Trial Units (CTUs) and divisional clinical research programs. Under the direction of the Director of Research Operations and in partnership with the Vice Chair for Clinical Research, leads the implementation, monitoring, and continuous improvement of departmental clinical research operations, policies, standard operating procedures, quality standards, and operational frameworks. Provides leadership and oversight to Clinical Research Managers and clinical research teams across the Department to ensure consistent, compliant, financially sustainable, and high-quality execution of clinical trials across multiple divisions and disease areas. Serves as the department-wide operational leader for study feasibility, startup, enrollment performance, regulatory compliance, OnCore governance, workforce planning, quality improvement, and clinical research operational excellence.

ESSENTIAL FUNCTIONS
Clinical Research Operations Leadership & CTU Oversight

• Provides direct and indirect leadership, operational oversight, and performance management of Clinical Research Managers and clinical research teams across Department of Medicine Clinical Trial Units and divisional clinical research programs.
• Establishes and monitors departmental performance expectations, operational standards, staffing models, service delivery metrics, and workforce utilization benchmarks across clinical research programs.
• Develops and implements standardized workflows and operational practices that promote consistency, efficiency, scalability, and quality across all CTUs.
• Collaborates with Division Chiefs, Principal Investigators, clinical research leadership, and institutional stakeholders to support successful study execution and program growth.
• Monitors operational performance, study activation timelines, enrollment activity, study workload, resource utilization, financial sustainability, and key performance indicators to inform decision-making and continuous improvement initiatives.

Clinical Trial Start-Up, Feasibility & Portfolio Management

• Oversees departmental processes for study feasibility review, protocol assessment, startup planning, study activation, enrollment monitoring, and ongoing portfolio management.

• Ensures implementation and adherence to departmental Clinical Research SOPs governing initial study feasibility, ongoing feasibility assessment, and investigator oversight.

• Oversees implementation of risk-based study feasibility and portfolio review processes to support effective resource allocation, study success, and responsible stewardship of departmental resources.

• Reviews operational, financial, enrollment, staffing, and regulatory considerations associated with new studies and active portfolios.

• Partners with Clinical Research Managers and investigators to identify operational risks and develop mitigation strategies that support study success and financial sustainability.

• Provides leadership for study prioritization, enrollment optimization, and operational planning across the clinical trial lifecycle

Regulatory Compliance, Quality & Systems Oversight

• Provides oversight of regulatory readiness, compliance monitoring, quality management, and adherence to institutional, sponsor, federal, and departmental requirements.
• Leads implementation and monitoring of departmental clinical research policies, SOPs, corrective action plans, and quality improvement initiatives.
• Oversees department-wide clinical research operational systems, including OnCore governance, study lifecycle management processes, reporting standards, data quality expectations, and workflow optimization.
• Coordinates internal audits, monitoring activities, risk assessments, corrective action plans, and remediation efforts to support research integrity, quality improvement, and regulatory compliance.
• Serves as a departmental resource regarding clinical research regulations, operational requirements, best practices, and process improvement opportunities.

Workforce Development, Financial Stewardship & Strategic Growth

• Leads workforce planning, staffing strategy, competency development, onboarding, succession planning, and professional development activities for clinical research personnel.
• Partners with Clinical Research Managers to evaluate staffing needs, workload distribution, organizational structure, and resource allocation.
• Oversees and supports the development and monitoring of clinical research operational budgets, study invoicing practices, financial performance metrics, coverage analysis implementation, and fiscal sustainability initiatives.
• Develops dashboards, reports, and operational analyses to support strategic planning and leadership decision-making.
• Identifies opportunities to expand clinical research capacity, improve investigator support, strengthen operational infrastructure, and advance departmental clinical research objectives.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 7 years of experience in clinical research and/or program management required
• Master's degree preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated experience managing multidisciplinary clinical research teams and supervising clinical research management staff preferred.
• Strong knowledge of clinical trial operations, study startup, participant enrollment, regulatory compliance, quality management, budgeting, and sponsor requirements preferred.
• Experience with clinical trial management systems, including OnCore, and clinical research operational reporting and metrics preferred.
• Proven ability to lead large-scale process improvement, standardization, and organizational change initiatives preferred.

LICENSES AND CERTIFICATIONS

• CLASP certification preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.