Asst Dir, Research Operations

University of Rochester; United States; On-site; USD 87,000 - 130,000; Full time

Job summary

The University of Rochester seeks an experienced clinical research operations leader to oversee Department of Medicine Clinical Trial Units and divisional research programs. The role centers on establishing standardized workflows, ensuring compliant, high-quality execution of trials, and guiding operational strategy across multiple divisions.

You will lead Clinical Research Managers and teams, drive feasibility, startup, enrollment monitoring, and governance, while coordinating with

Responsibilities

• Leads operational leadership for Clinical Research Managers and teams across Department of Medicine CTUs and divisional programs.
• Establishes performance expectations, standards, staffing models, service delivery metrics, and workforce utilization benchmarks.
• Develops standardized workflows to promote consistency, efficiency, scalability and quality across CTUs.
• Collaborates with Division Chiefs, principal investigators and stakeholders to support study execution and program growth.
• Monitors study feasibility, startup, enrollment, regulatory compliance, governance, workforce planning and quality improvement.

Job description

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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,