Senior Clinical Research Specialist

About the Work Unit:
Our research mission is to transform the discipline of nursing through research, practice and partnerships and to contribute to the social advancement and health of Tennessee, the nation, and the world.  Vanderbilt School of Nursing (VUSN) supports the development of innovative research programs within VUSN that align strategically with other Vanderbilt University initiatives and that address national priorities to promote and protect health.  The Center for Research Development and Scholarship supports many activities related to pre-award and post-award, federal and non-federal grant submission and other scholarship activities.

Key Functions and Expected Performance:

Study Operations and Execution

• Independently develop and implement comprehensive operational plans to execute complex clinical research protocols.
• Design and optimize site-specific workflows to ensure efficiency, protocol fidelity, and timely study completion.
• Conduct protocol-required procedures, including cognitive and functional assessments, and participant visits.
• Lead recruitment and retention efforts using data-informed strategies to achieve enrollment targets.
• Identify and resolve operational challenges proactively while coordinating multidisciplinary teams and study stakeholders.

Regulatory Compliance, Safety and Data Integrity

• Ensures full compliance with funding sources, HIPAA, IRB, and institutional requirements.
• Prepare and manage IRB submissions, amendments, continuing reviews, and reportable events.
• Implement safety monitoring processes, including timely identification and reporting of adverse events.
• Maintain audit-ready regulatory documentation and oversee sponsor monitoring visits.
• Manage secure data systems (e.g., REDCap), including database development, access controls and quality assurance reviews.

Research Development, Education and Scholarly Contribution

• Contribute to grant submissions through feasibility assessments, recruitment planning, regulatory strategy, and data management planning.
• Participate in the development of abstracts, presentations, and scholarly dissemination materials.
• Develop instructional and training materials using adult learning principles and instructional design frameworks.
• Deliver educational presentations to research participants, community partners, and internal stakeholders.
• Maintain subject-matter expertise through continuing education and provide informal mentorship to junior research staff.

Education, Certifications and License:

• Bachelor's degree required
• Master's degree preferred in related field

Experience and Skills:

• Minimum 5 years of experience in a research setting is required.
• Experience managing the coordination of complex schedules is necessary.
• Experience with research informed consent/assent processes is preferred.