This position is responsible for the data management functions and conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.
The Vanderbilt Vaccine Research Program was formed in 2001 to conduct clinical and translational research in vaccines, vaccine preventable diseases, and pediatric infectious diseases. Led since 2014 by Dr. Buddy Creech, Associate Professor of Pediatric Infectious Diseases, the mission of the VVRP is to reduce the burden of infectious diseases worldwide through the discovery, evaluation, and delivery of effective and safe vaccines and therapeutics.
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Inputs, reviews and submits eligibility documentation into data capture systems for a portfolio of studies. Identifies and resolves any documentation discrepancies.
Correctly and efficiently abstracts information from the EMR for multiple studies. Able to manage additional assignments as needed for fast accruing studies.
Identifies AEs from EMR, provides support to correctly and completely record AEs and serves as resource to CTA II staff. Assists with trending reports on AEs for each trial and across teams.
Submits to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials. Acts as preceptor for CTA II staff.
Reviews and approves responses to sponsor queries from CTA IIs. Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification on ongoing issue
External Sponsor Monitoring and Visit Management
Coordinates 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 effective communication with external monitors. Mentors data team on resolving issues.
Quality Assurance/Internal Monitoring
Queries research team to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Mentors and trains CTA II staff to communicate effectively with the research team as needed.
Identifies and resolves discrepancies with research team. Mentors and assists data team in effective discrepancy resolution as needed.
Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
Trains CTA II staff in good clinical and research practices as it relates to data management as needed. Encourages input as it relates to process improvement.
Prepares for and participates in clinical trial audits. Mentors and trains CTA II staff to prepare for and participate in internal and external audits as needed.
Bachelors Diploma (or equivalent experience) and 3 years experience required.
Drug Information Association Inc