Clinical Research Quality Compliance Coordinator - VICTR - VCC
Supports front line leadership with developing, recommending, and implementing clinical research quality improvement and compliance initiatives through audit, 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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Develops and Implements clinical research quality initiatives
Acts as liaison between investigators, agencies, sponsoring companies, regulatory committees, and other participants.
Demonstrates proficiency in identifying, defining, and analyzing metrics and goals.
Supports the development of programs and plans to support quality improvement objectives
Collect data and develop/utilize appropriate metrics for facilitation of case reviews and root cause analyses.
Provide advice, guidance, and problem resolution to Principal Investigator 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 of findings.
QUALITY ASSURANCE (INTERMEDIATE)
Coordinate, implement and analyze quality processes that ensure clinical research compliance with regulatory and VUMC Quality Control/Quality Assurance/Quality Management standards.
Organize and perform random, for-cause, and regulatory committee-requested audits of clinical research studies, as appropriate, to ensure compliance with applicable regulations and guidelines.
Support the development of clinical research programs and plans to support quality improvement objectives.
Develop and implement clinical research quality improvement projects and initiatives and serve as a member of project teams.
Serve as a resource for clinical research policy and standards interpretation, and ensure utilization in operations.
Maintain a current knowledge of federal and state laws, as well as VUMC regulations and guidelines governing human subjects research.
PROCESS IMPROVEMENT (INTERMEDIATE)
Participate in clinical research process improvement projects and tasks including providing expertise and guidance during organizational meetings.
Develop and update clinical research documentation that can be communicated efficiently to all levels within the project.
Coordinate timely communication of quality management initiatives.
Summarize data in a format that will facilitate identification and prioritization of improvement initiatives.
Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest clinical research 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.
Develop audience-appropriate presentations regarding clinical research quality and compliance issues and implementations.
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.