Clinical Research Quality Compliance Coordinator ***REMOTE AVAILABLE***
Supports front line leadership with developing, recommending, and implementing clinical research quality improvement and compliance initiatives through data collection, analysis, change management, and communication.
About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org .
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DATA ANALYSIS (INTERMEDIATE):
- Collect data and develop/utilize appropriate metrics for facilitation of case reviews and root cause analysis. Provide advice, guidance, and problem resolution to PI on protocol design/development and data collective mechanisms. Demonstrate proficiency in identifying, defining, and analyzing metrics and goals. Utilize quality management and statistical process control tools and methods as appropriate. Analyze data and prepare audit reports and summaries, findings are presented to the Committee(s)
QUALITY ASSURANCE (INTERMEDIATE)
- Coordinate, implement and analyze quality processes that ensure compliance with regulatory and company Quality Control/Quality Assurance/Quality Management standards. Organizes and performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate
to ensure compliance with applicable regulations and guidelines. Supports the development of programs and plans to support quality improvement objectives. Lead quality improvement projects and initiatives within the department and serve as a member of project teams. Develop and implement quality initiatives for the department. Serve as a resource for policy/standard interpretation and application to operations. Maintain a current knowledge of Federal, State, and University laws, regulations, guidelines governing human subject research
PROCESS IMPROVEMENT (INTERMEDIATE):
- Participate in process improvement projects and tasks including providing consultative services during organizational meetings. Develop and update board documentation that can be communicated efficiently to all levels within the entity. Coordinate timely communication of quality management initiatives. Summarize date in a format that will facilitate identification and prioritization of improvement initiatives. Participate in the development teams' vision and strategies and contributes to the development of educational improvement programs. Participate in multi-disciplinary performance improvement teams and demonstrates engagement in supporting team objectives. Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training with staff development for on-site and off-site personnel as required
- Communicate with internal and external customers without requiring support and instruction from others. Meet with leadership and customers to elicit training, education and compliance requirements and identify the relationship between them. Develop audience appropriate presentations regarding project issues and implementations. Share knowledge, ideas and information openly, effectively sell new