YOUR ROLE: In your pivotal role as a Sr. Clinical ResearchData Specialist you will function independently and in a supervisory role forall team members that are assigned. You will be responsible for managing dataquality, data review, and data backup. Additional responsibilities includemanaging monitor visits and upcoming audits/data locks in accordance with GoodClinical 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 forClinical and Translational Research (VICTR), which is of strategicimportance to our institution and its research operation, is to removeimpediments to translational science so that innovations reach the people whoneed them more quickly. We are a workforce united not only by commonpurpose but also by common values.
In collaboration with the VUMC Human ResearchProtections Program (HRPP), the Translational Research Navigator II assistswith the optimal application of the Federal, State, and local laws, guidancedocuments, VUMC Institutional policies, and Institutional Review Board (IRB)policies and procedures while meeting the objectives of the VUMC researchcommunity. Consults on complex research and regulatory issues in conjunctionwith the team(s) to identify solutions and develop improvement processes. TheTRN II researches topics of departmental, institutional or strategicimportance.
Located in Nashville, Tennessee, and operatingat a global crossroads of teaching, discovery and patient care, VUMC is acommunity of individuals who come to work each day with the simple aim ofchanging the world. It is a place where your expertise will be valued, yourknowledge expanded, and your abilities challenged. It is a place where yourdiversity â of culture, thinking, learning and leading â is sought andcelebrated. It is a place where employees know they are part of something thatis bigger than themselves, take exceptional pride in their work and neversettle for what was good enough yesterday. Vanderbiltâs mission is to advancehealth and wellness through preeminent programs in patient care, education, andresearch.
VUMC Recent Accomplishments:
Because we are committed to providing the bestin patient care, education and research, we are proud of our recentaccomplishments.
US News & World Report: #1 Hospital in Tennessee, #1 HealthCare Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 12 adult and10 pediatric clinical specialties ranked among the nation's best, #15 Educationand Training
Truven Health Analytics: among the top 50 cardiovascular hospitalsin the U.S.
Becker's Hospital Review: one of the "100 Greatest Hospitalsin America"
The Leapfrog Group: grade "A" in Hospital Safety Score
National Institutes of Health: among the top 10 grant awardees formedical research in the US
Magnet Recognition Program: Vanderbilt nurses are the only grouphonored in Middle Tennessee
Nashville Business Journal: Middle Tennessee's healthiest employer
American Hospital Association: among the 100 "MostWired" medical systems in the US
Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.