YOUR ROLE: In your pivotal role as a Sr. Clinical Research Data Specialist you will function independently and in a supervisory role for all team members that are assigned. You will be responsible for managing data quality, data review, and data backup. Additional responsibilities include managing monitor visits and upcoming audits/data locks in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.
Bachelor's Degree (or equivalent experience) and 5 years relavent experience required
Reviews and submits eligibility documentation into data capture systems for complex studies (phase I, molecular based studies, etc.) Identifies and resolves any documentation discrepancies. Collaborates with regulatory to ensure eligibility criteria are clearly defined and tools to support eligibility processes are in place.
Correctly and efficiently abstracts information from the EMR for multiple studies. Accountable for managing diverse assignments and supervise other staff as needed for fast accruing studies.
Accountable for accurate and timely reporting of all AEs from EMR, assists team members to correctly and completely record AEs and serves as resource to data team. Responsible for timely communication to principal investigator and study sponsor of any AE trends and all safety issues.
Accountable and responsible for timely submission of all data in carious EDC systems. Monitors documentation for quality and accuracy. Initiates and develops processes to increase efficiency and accuracy of data entry. Manages day to day operational needs as it relates to real time data capture and provides coverage as needed.
Manages sponsor queries to ensure timely response and appropriate communication with PI and study sponsor. Oversees prioritization of studies of high importance (e.g. high accrual, Phase I, meeting data lock, etc.) and assigns work to data team.
External Sponsor Monitor and Visit Management
Oversees the monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations.
Meets with monitors to review data monitoring results, answer questions and resolve queries. Demonstrates expert communication with external monitors and sponsors. Mentors data team on resolving issues. Collaborates with PI and QA manager to ensure monitor visits are effective and accurately completed. Identifies unbudgeted requests and discusses with manager and budget analyst to ensure proper billing for work provided.
Quality Assurance/Internal Monitoring
Queries research ream to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Assists data team to communicate effectively with the research team. Collaborates with QA trainer to identify areas for education and quality improvement.
Accountable to resolve all data and EMR discrepancies. Mentors data team in effective discrepancy resolution. Collaborates with QA trainer to identify areas for education and quality improvement.
Manages data entry, data lock, monitoring and audit deadlines for complex clinical trial portfolio. Trains and mentors data team in prioritizing deadlines. Escalates any issues related to meeting data deadlines to manager.
Trains and mentors data team on good clinical and research practices, processes and all regulations as it relates to clinical research and data management. Works with manager on continuous process improvement initiatives.
Coordinates and participates in assigned clinical trial audits. Assists data team to prepare for and participate in internal and external audits. Works with Assistant Director of Compliance and QA Manager to understand audit trends, respond to audit findings and develop corrective action plans.
The mission of the Vanderbilt Institute for Clinical and Translational Research (VICTR) , which is of strategic importance to our institution and its research operation, is to remove impediments to translational science so that innovations reach the people who need them more quickly. We are a workforce united not only by common purpose but also by common values.
In collaboration with the VUMC Human Research Protections Program (HRPP), the Translational Research Navigator II assists with the optimal application of the Federal, State, and local laws, guidance documents, VUMC Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VUMC research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The TRN II researches topics of departmental, institutional or strategic importance.
Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.
VUMC Recent Accomplishments:
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments.
US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
The Leapfrog Group: grade "A" in Hospital Safety Score
National Institutes of Health: among the top 10 grant awardees for medical research in the US
Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
Nashville Business Journal: Middle Tennessee's healthiest employer
American Hospital Association: among the 100 "Most Wired" medical systems in the US
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 th...e 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.