Senior Clinical Research Specialist
Vanderbilt University
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.
At Vanderbilt University , our work - regardless of title or role - is in service to an important and noble mission in which every member of our community serves in advancing knowledge and transforming lives on a daily basis. Located in Nashville, Tennessee, on a 330+ acre campus and arboretum dating back to 1873, Vanderbilt is proud to have been named as one of “America’s Best Large Employers” as well as a top employer in Tennessee and the Nashville metropolitan area by Forbes for several years running. We welcome those who are interested in learning and growing professionally with an employer that strives to create, foster and sustain opportunities as an employer of choice.
We understand you have a choice when choosing where to work and pursue a career. We understand you are unique and have a story. We want to hear it. We encourage you to apply today so that you might become a part of our story.
The Senior Clinical Research Specialist is part of the Vanderbilt School of Nursing and independently leads the operational, regulatory and technical execution of complex clinical research studies. This role serves as the primary study level operational authority, ensuring regulatory compliance, data integrity, participant safety and successful achievement of study aims. The Senior Clinical Research Specialist assures that the quality of the research is maintained and that the research is conducted in accordance with Vanderbilt Institutional Review Board (IRB) regulations, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. This is a part time, fully remote position that directly reports to the Principal Investigator.