The Clinical Research Data Specialist (CRDS) will be housed in the Vanderbilt Coordinating Center (the central clinical trial office within the Vanderbilt Institute for Clinical and Translational Research). The CRDS will play a critical role within the Program for Investigator Initiated Trials in the VCC. The CRDS serves to support their lead Clinical Trials Operations Manager by focusing on data management process and monitoring for investigator initiated trials managed by the VCC. The CRDS is critical to ensuring that a study's endpoints can be properly assessed by acting as the first line of defense for all data oversight. The CRDS ensures data collected at participating centers is accurate, initiates data adjudication processes, solves operational problems, informs best practices for data management, and prepares a wide range of statistical reports. This position is responsible for data management of human studies involving pharmaceuticals, biologics, and/or devices and for supporting and informing the corresponding Clinical Trial Operations Manager as needed.
· May assist Clinical Trial Operations Managers or Clinical Research Navigators with study start-up activities including system set-up, monitoring plan creation, database construction and study tracking.
· Maintains effective working relationships with study team, study PI, and participating sites. Consults with other VCC employees to solve operational or data problems. Reports to the applicable Clinical Trial Operations Manager.
· Assists with the assessment of a project's status, task completion, and staff productivity in order to keep study milestones on track. Determines status of incoming data, site responsiveness, need for the development of a customized action plan in order to address and prevent issues, and the need for additional support from leadership within the VCC, other VUMC departments, or within the external participating sites in order to solve outstanding issues.
· Generates data retrievals and summaries and performs data analysis as needed for Clinical Trial Operations Managers, study Principal Investigators, Steering Committees, Safety Monitors, and for Data Safety Monitoring Boards.
· Validates clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
· Possesses an eagerness to learn about the many diverse therapeutic areas, both surgical and medical as well as adult and pediatric, supported by the VCC.
· Collaborates with research informatics within VICTR and the VCC in an effort to develop new functionality and electronic applications to support data management when novel approaches are required in order to operationalize a new study or to support general workflow across the VCC.
· Reviews electronic case report forms for completeness and consistency. Queries data inconsistencies and revises case report forms in compliance with standard operating procedures as needed. Reviews and approves post production changes to active study databases in order to control study documentation and workflow.
· Implements strategy for data cleaning and the design and programming of study databases. Prioritizes work in line with project management decisions.
· Maintains a thorough understanding of clinical data management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
· May attend internal and external project meetings in order to provide input from a CRDS perspective. May provide input to the study PI and sponsor as needed when issues surrounding data management are negatively impacting a study's progress.
· Serves as a valuable resource to other VCC colleagues for data management best practices and tools. May develop and give internal and external presentations in order to increase education and awareness of proper data management and project management techniques.
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.
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