Clinical Research Operations Analyst II Full-time

Clinical Research Operations Analyst II

The Clinical Trials Office within the Office of Research at Dell Medical School is seeking a Clinical Research Operations Analyst II.

This position 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.

Essential Job Functions

• Supports operational coordination across centralized clinical research services including study start-up, regulatory support, research coordination services, and recruitment infrastructure.
• Performs operational analyses that support clinical research program performance, service utilization, and operational capacity planning.
• Assists with development of standardized operating procedures, workflow documentation, and operational guidance resources used by research teams.
• Supports implementation of new research operational programs, service lines, and infrastructure initiatives within the Clinical Trials Office.
• Coordinates operational initiatives that improve efficiency, consistency, and scalability of clinical research operations.

• Develops and maintains operational dashboards and performance reports related to study activation timelines, enrollment performance, regulatory submissions, and operational service delivery.
• Analyzes data from research systems such as Clinical Trial Management Systems (CTMS), Epic Research, and electronic regulatory platforms to identify operational trends and performance gaps.
• Prepares operational reports and analytics used by research leadership to support strategic planning and operational decision-making.
• Assists with development of standardized performance metrics used to monitor clinical research program effectiveness.

• Coordinates operational workflows across research technology platforms including Epic Research, Clinical Trial Management Systems (CTMS), and electronic regulatory systems.
• Supports configuration, testing, validation, and optimization of research operational workflows within research systems.
• Works with Research IT and operational stakeholders to ensure research technology systems align with operational workflows and regulatory requirements.
• Supports research system implementation activities including testing, workflow validation, and operational readiness planning.

• Leads operational improvement initiatives focused on reducing study activation timelines, improving research coordination efficiency, and enhancing regulatory workflow consistency.
• Identifies operational inefficiencies and recommends workflow redesign or system improvements.
• Supports implementation of standardized tools, templates, and operational resources used across research programs.
• Monitors operational performance and helps implement corrective actions to address workflow bottlenecks.

• Collaborates with research administration units including research contracts, regulatory affairs, compliance, finance, and clinical operations.
• Serves as a liaison between research operational teams and research technology partners.
• Supports coordination of enterprise research initiatives impacting clinical trial operations.

• Participates in research system upgrades, configuration testing, and research system go-live preparation.
• Supports onboarding of new research programs or departments into centralized research operational services.
• Participates in operational workgroups and committees focused on research infrastructure and process improvement.
• Adheres to internal controls and reporting structure.

Knowledge/Skills/Abilities

• Integrity and Trust
• Demonstrates ethical conduct and maintains strict confidentiality when handling sensitive research, regulatory, financial, and participant information.
• Escalates potential operational or compliance concerns and documents supporting operational determinations when appropriate.
• Safeguards protected health information (PHI) and confidential sponsor or institutional research information.
• Process Management
• Supports development and management of standardized clinical research operational processes including study start-up workflows, regulatory submission coordination, and research coordination service models.
• Contributes to development of operational tools, workflow documentation, and guidance materials used by research teams.
• Supports continuous improvement initiatives aimed at improving operational efficiency and compliance.
• Managing and Measuring Work
• Manages multiple operational initiatives and reporting activities simultaneously while maintaining accuracy and documentation quality.
• Monitors operational performance metrics including activation timelines, service delivery performance, and research system utilization.
• Supports development of operational reporting frameworks used to evaluate clinical research program performance.
• Problem Solving
• Uses operational data, research system reports, and workflow analysis to identify operational challenges and recommend solutions.
• Investigates workflow discrepancies by reconciling protocol requirements, regulatory obligations, operational procedures, and system configurations.
• Supports implementation of sustainable improvements through workflow redesign, documentation updates, and staff training.
• Customer Focus
• Supports investigators and research teams by helping navigate operational processes and research infrastructure.
• Provides operational guidance related to clinical trial workflows, research systems, and centralized research services.
• Maintains strong collaborative relationships with research administration and clinical operations teams.
• Communicating Effectively
• Communicates clearly with research staff, investigators, and institutional stakeholders.
• Prepares operational reports, workflow documentation, and training materials.
• Assists with presentation of operational metrics and performance reports to research leadership.
• Dealing with Ambiguity
• Remains effective under changing operational priorities, evolving regulatory requirements, and new research initiatives.
• Supports operational continuity during research system implementations, workflow changes, and institutional process updates.

Education & Experience

Minimum Qualifications:

• Bachelor's degree in Healthcare Administration, Public Health, Life Sciences, Business Administration, or related field. 2 years of experience in clinical research operations, research administration, program coordination, research systems support, or related healthcare operations roles. Experience supporting clinical trial operational workflows including study start-up, regulatory coordination, research coordination services, or research program administration. Experience working with research technology systems such as Clinical Trial Management Systems (CTMS), electronic regulatory platforms, or electronic health record research modules.

Preferred Qualifications:

• Experience supporting operational analytics, performance reporting, or research program management within an academic medical center. Experience supporting research system implementations or research operational infrastructure development. Knowledge of Good Clinical Practice (GCP), human subjects research regulations, and FDA-regulated clinical research environments.

Salary Range

$61,039 + depending on qualifications

LICENSES, REGISTRATIONS OR CERTIFICATIONS

Required:

None

Preferred:

• ACRP or SOCRA certification (CCRP, CCRC, or equivalent clinical research certification)
• Training related to Good Clinical Practice (GCP) or clinical research compliance
• Experience with Epic Research Module and/or Clinical Trial Management Systems (CTMS)

WORKING ENVIRONMENT/EQUIPMENT

• Standard office equipment
• Repetitive use of a keyboard
• Occasional interaction with clinical research staff in clinical environments

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.

Important for Current university