Clinical Research Operations Analyst II

Clinical Research Operations Analyst II

Dell Medical School is seeking a Clinical Research Operations Analyst II. This position supports advanced operational activities within the Clinical Trials Office (CTO). It leads operational analysis, performance reporting, workflow optimization, and research systems coordination that support the clinical trial lifecycle across centralized clinical research services. Working under the direction of the Senior Manager, Clinical Research Operations, this role supports development and implementation of standardized operational processes, performance dashboards, and research technology integrations that enable efficient and compliant clinical trial operations.

The Analyst II provides operational insights, manages operational improvement initiatives, and supports cross-functional coordination across research administration, regulatory affairs, research finance, and clinical operations. This role contributes to the development of scalable operational infrastructure that supports growth of the institutional clinical research enterprise.

The essential job functions include:

• Supporting operational coordination across centralized clinical research services including study start-up, regulatory support, research coordination services, and recruitment infrastructure.
• Performing operational analyses that support clinical research program performance, service utilization, and operational capacity planning.
• Assisting with development of standardized operating procedures, workflow documentation, and operational guidance resources used by research teams.
• Supporting implementation of new research operational programs, service lines, and infrastructure initiatives within the Clinical Trials Office.
• Coordinating operational initiatives that improve efficiency, consistency, and scalability of clinical research operations.
• Developing and maintaining operational dashboards and performance reports related to study activation timelines, enrollment performance, regulatory submissions, and operational service delivery.
• Analyzing data from research systems such as Clinical Trial Management Systems (CTMS), Epic Research, and electronic regulatory platforms to identify operational trends and performance gaps.
• Preparing operational reports and analytics used by research leadership to support strategic planning and operational decision-making.
• Assisting with development of standardized performance metrics used to monitor clinical research program effectiveness.
• Coordinating operational workflows across research technology platforms including Epic Research, Clinical Trial Management Systems (CTMS), and electronic regulatory systems.
• Supporting configuration, testing, validation, and optimization of research operational workflows within research systems.
• Working with Research IT and operational stakeholders to ensure research technology systems align with operational workflows and regulatory requirements.
• Supporting research system implementation activities including testing, workflow validation, and operational readiness planning.
• Leading operational improvement initiatives focused on reducing study activation timelines, improving research coordination efficiency, and enhancing regulatory workflow consistency.
• Identifying operational inefficiencies and recommending workflow redesign or system improvements.
• Supporting implementation of standardized tools, templates, and operational resources used across research programs.
• Monitoring operational performance and helping implement corrective actions to address workflow bottlenecks.
• Collaborating with research administration units including research contracts, regulatory affairs, compliance, finance, and clinical operations.
• Serving as a liaison between research operational teams and research technology partners.
• Supporting coordination of enterprise research initiatives impacting clinical trial operations.
• Participating in research system upgrades, configuration testing, and research system go-live preparation.
• Supporting onboarding of new research programs or departments into centralized research operational services.
• Participating in operational work groups and committees focused on research infrastructure and process improvement.
• Adhering to internal controls and reporting structure.

The knowledge, skills, and abilities required include:

• Demonstrating ethical conduct and maintaining strict confidentiality when handling sensitive research, regulatory, financial, and participant information.
• Supporting development and management of standardized clinical research operational processes including study start-up workflows, regulatory submission coordination, and research coordination service models.
• Managing multiple operational initiatives and reporting activities simultaneously while maintaining accuracy and documentation quality.
• Using operational data, research system reports, and workflow analysis to identify operational challenges and recommend solutions.
• Communicating clearly with…