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About the Role
The University of Rochester is seeking a leader to provide operational leadership, oversight, and standardization of clinical research activities across its Department of Medicine Clinical Trial Units and divisional research programs. This role is crucial for implementing, monitoring, and improving clinical research operations, ensuring compliance, financial sustainability, and high-quality execution of clinical trials.
Responsibilities
- Provides operational leadership, oversight, and standardization of clinical research activities.
- Leads the implementation, monitoring, and continuous improvement of departmental clinical research operations, policies, and standard operating procedures.
- Provides leadership and oversight to Clinical Research Managers and teams to ensure consistent, compliant, and high-quality execution of clinical trials.
- Serves as the departmental operational leader for study feasibility, startup, enrollment performance, regulatory compliance, workforce planning, and quality improvement.
- Provides direct and indirect leadership, operational oversight, and performance management of Clinical Research Managers and clinical research teams.
- Establishes and monitors departmental performance expectations, operational standards, staffing models, and service delivery metrics.
- Develops and implements standardized workflows and operational practices for consistency, efficiency, and quality.
- Collaborates with Division Chiefs, Principal Investigators, and stakeholders to support study execution and program growth.
- Monitors operational performance, study activation timelines, enrollment activity, resource utilization, and financial sustainability.
- Oversees departmental processes for study feasibility review, protocol assessment, startup planning, and enrollment monitoring.
- Ensures implementation and adherence to departmental Clinical Research SOPs.
- Oversees implementation of risk-based study feasibility and portfolio review processes.
- Reviews operational, financial, enrollment, staffing, and regulatory considerations for new studies and active portfolios.
- Partners with Clinical Research Managers and investigators to identify operational risks and develop mitigation strategies.
- Provides leadership for study prioritization, enrollment optimization, and operational planning.
- Provides oversight of regulatory readiness, compliance monitoring, quality management, and adherence to requirements.
- Leads implementation and monitoring of departmental clinical research policies, SOPs, and quality improvement initiatives.
- Oversees department-wide clinical research operational systems, including OnCore governance and study lifecycle management.
- Coordinates internal audits, monitoring activities, risk assessments, and remediation efforts.
- Serves as a departmental resource regarding clinical research regulations, operational requirements, and best practices.
- Leads workforce planning, staffing strategy, competency development, and professional development for clinical research personnel.
- Partners with Clinical Research Managers to evaluate staffing needs, workload distribution, and resource allocation.
- Oversees and supports the development and monitoring of clinical research operational budgets, study invoicing, and fiscal sustainability initiatives.
- Develops dashboards, reports, and operational analyses for strategic planning.
- Identifies opportunities to expand clinical research capacity and advance departmental objectives.
Requirements
- Bachelor's degree and 7 years of experience in clinical research and/or program management required.
- Master's degree preferred.
- Equivalent combination of education and experience may be considered.
- 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.
Skills
- Clinical research operations
- Program management
- Leadership
- Oversight
- Standardization
- Clinical trial management systems (OnCore)
- Regulatory compliance
- Quality management
- Budgeting
- Sponsor requirements
- Process improvement
- Organizational change management
Location
- 601 Elmwood Ave, Rochester, New York, United States of America, 14642
Work Type
- Full time
- 40 hours per week
Experience Level
- 7 years of experience in clinical research and/or program management
Education Level
- Bachelor's degree
- Master's degree preferred
Salary/Compensations
- $86,900.00 - $130,300.00
About the Company
- 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.
Equal Opportunity
- 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.