Research Quality Analyst - Hybrid in Nashville TN
Located in Nashville, Tennessee, Vanderbilt University Medical Center (VUMC) operates at a global crossroads of teaching, discovery, and patient care. It is a community where expertise is valued, knowledge is expanded, and abilities are challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and uniqueness is celebrated.
About the Role
The Oncology Research Quality Analyst ensures the accuracy, completeness, and quality of clinical trial eligibility documentation through detailed secondary reviews of patient eligibility checklists. This role serves as a critical quality control function, validating that eligibility determinations are supported by appropriate clinical documentation and align with study protocol requirements. The analyst also develops, maintains, and updates eligibility checklist templates throughout the lifecycle of clinical trials. Additionally, this position supports continuous improvement initiatives by conducting chart reviews, analyzing quality data, identifying trends, and generating reports related to compliance, error rates, and process outcomes. This is a highly analytical and detail-oriented role requiring independent decision-making, exceptional accuracy, and the ability to work autonomously in a fast-paced research environment.
Responsibilities
- Perform second review of research participant eligibility checklists for accuracy and completeness to ensure participant safety and research integrity.
- Create eligibility checklist templates based on protocol-specific requirements during study startup.
- Update eligibility checklist templates with each protocol amendment for actively accruing studies.
- Perform chart reviews of study participants for accuracy and completeness, including informed consent notes, study visit narrative notes, and adverse event logs.
- Compile data from chart reviews to determine trends.
- Create and maintain reporting tools, metrics, and data for tracking site performance, study outcomes, performance improvement, and process effectiveness.
Requirements
- 3+ years of experience in Oncology.
- Proficiency in Microsoft Office Suite, with strong skills in Word and Excel.
- Strong technical aptitude and comfort navigating various systems and software applications.
- 3+ years of research experience in a clinical, scientific, or related environment.
- Strong analytical and critical thinking skills.
- Exceptional attention to detail with a commitment to accuracy and quality.
- Demonstrated ability to work independently, manage priorities, and perform effectively with minimal supervision.
- Bachelor's degree.
Technical Capabilities
- Clinical Research (Intermediate): Able to research problems spanning several areas of the department. Knowledgeable about available information within the organization. Designs data collection forms. Possesses networking skills to assist in researching issues.
- Project Tracking & Reporting (Intermediate): Able to track project progress and report on status.
- Research Administration (Intermediate): Knowledgeable of all phases of the Clinical Trial lifecycle. Familiar with Good Clinical Practice and Good Documentation Practice guidelines. Assists researchers in reducing compliance risks and supports routine and specialized processes.
Core Accountabilities
- Organizational Impact: Executes job responsibilities with an understanding of how output impacts other areas related to the job or team.
- Problem Solving/Complexity of Work: Analyzes moderately complex problems using technical experience and judgment.
- Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.
- Team Interaction: Provides informal guidance and support to team members.
Core Capabilities
- Supporting Colleagues:
- Develops Self and Others: Invests time and energy in developing self and others to improve performance and gain knowledge.
- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders to expand and strengthen relationships.
- Communicates Effectively: Recognizes group interactions and modifies communication style to suit different situations and audiences.
- Delivering Excellent Services:
- Serves Others with Compassion: Seeks to understand current and future needs of stakeholders and customizes services accordingly.
- Solves Complex Problems: Approaches problems from different angles and identifies new opportunities for improvement.
- Offers Meaningful Advice and Support: Provides ongoing support and coaching to increase employees' effectiveness.
- Ensuring High Quality:
- Performs Excellent Work: Engages in dialogue about quality and addresses issues promptly.
- Ensures Continuous Improvement: Applies learning experiences to uncover underlying causes of problems and identify solutions.
- Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks.
- Managing Resources Effectively:
- Demonstrates Accountability: Focuses on and drives critical issues to closure.
- Stewards Organizational Resources: Applies understanding of departmental work to manage resources effectively.
- Makes Data-Driven Decisions: Demonstrates strong understanding of data to identify and elevate opportunities.
- Fostering Innovation:
- Generates New Ideas: Proactively identifies new ideas and opportunities from multiple sources.
- Applies Technology: Demonstrates enthusiasm for learning new technologies, tools, and procedures.
- Adapts to Change: Views difficult situations as opportunities for improvement and embraces change.
Schedule
8:00 AM - 5:00 PM CST, Monday - Friday.
Benefits
This role offers a comprehensive benefits package which may include health, disability, retirement, and/or wellness offerings to enhance well-being and professional growth.