Vanderbilt University Medical Center Senior Clinical Research Data Specialist , Phase I - VICC in Nashville, Tennessee
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This position functions independently and in a supervisory role for all team members that are assigned. This position is 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. For more information regarding the physical requirements and environmental conditions for this job, please click here at https://hr.mc.vanderbilt.edu/careers/requirements/PhysicalRequirementsGroup57.pdf .
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.
JOB CODE INFORMATION:
Job Code: 3747
Job Stream Description: TBD
Bachelor's Degree (or equivalent experience) and 5 years experience
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 at http://www.vanderbilthealth.com/billwilkerson/ ), 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 Tennessee
Nashville Business Journal: Middle Tennessee's healthiest employer
American Hospital Association: among the 100 "Most Wired" medical systems in the US
Download the Vanderbilt University Medical Center Facts 2016-2017 at https://www.vanderbilthealth.com/main/39107 to learn more about our services and facilities.
Organization: VICC- Clinical Trials 50 104265
Title: Senior Clinical Research Data Specialist , Phase I - VICC
Location: TN-Nashville-3322 West End Avenue
Requisition ID: 1804984