Vanderbilt University Medical Center Clinical Research Data Specialist in Nashville, Tennessee

Clinical Research Data Specialist –VICTR Vanderbilt Coordinating Center - VCC

Requisition Number 1810174

JOB SUMMARY

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.

JOB RESPONSIBILITIES

  • May assist Clinical Trial Operations Managers or ClinicalResearch 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 tosolve operational or data problems.Reports to the applicable Clinical Trial Operations Manager.

  • Assistswith the assessment of a project’s status, task completion, and staffproductivity in order to keep study milestones on track. Determines status of incoming data, siteresponsiveness, need for the development of a customized action plan in orderto address and prevent issues, and the need for additional support fromleadership within the VCC, other VUMC departments, or within the externalparticipating sites in order to solve outstanding issues.

  • Generatesdata retrievals and summaries and performs data analysis as needed for ClinicalTrial Operations Managers, study Principal Investigators, Steering Committees,Safety Monitors, and for Data Safety Monitoring Boards.

  • Validatesclinical trial data to ensure consistency, integrity and accuracy based onproject specific guidelines.

  • Possessesan eagerness to learn about the many diverse therapeutic areas, both surgicaland medical as well as adult and pediatric, supported by the VCC.

  • Collaborateswith research informatics within VICTR and the VCC in an effort to develop newfunctionality and electronic applications to support data management when novelapproaches are required in order to operationalize a new study or to supportgeneral workflow across the VCC.

  • Reviewselectronic case report forms for completeness and consistency.Queries data inconsistencies and revises casereport forms in compliance with standard operating procedures as needed.Reviews and approves post production changesto active study databases in order to control study documentation and workflow.

  • Implementsstrategy for data cleaning and the design and programming of study databases.Prioritizes work in line with projectmanagement decisions.

  • Maintainsa thorough understanding of clinical data management tasks and assignedprotocol(s) with ability to critically evaluate the information in relation toother key project documents and processes.

  • Mayattend internal and external project meetings in order to provide input from aCRDS perspective. May provide input to the study PI and sponsor as needed whenissues surrounding data management are negatively impacting a study’s progress.

  • Servesas a valuable resource to other VCC colleagues for data management bestpractices and tools.May develop andgive internal and external presentations in order to increase education andawareness of proper data management and project management techniques.

Required Skills

  • Bachelor's Degree Preferred

  • 3 Years of Relevant Experience Required

Department Summary

VICTR is Vanderbilt's virtual home for clinical and translational research. Supported by the Vanderbilt Office of Research and the NIH sponsored Clinical and Translational Science Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. This is accomplished using a multi-faceted approach: through collaboration with a wide variety of research partners; by training, nurturing and rewarding participating researchers; by funding research; by developing new and innovative ways to involve the community in research; by developing new informatics and biostatistical systems; and by making available the latest technologies and sound research results affecting patient care.

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 Middle Tennessee

· Nashville Business Journal: Middle Tennessee's healthiest employer

· American Hospital Association: among the 100 "Most Wired" medical systems in the US

*CA

Physical Requirements/Strengths needed & Physical Demands:

Movement

  • Occasional: Sitting: Remaining in seated position

  • Occasional: Standing: Remaining on one's feet without moving.

  • Occasional: Walking: Moving about on foot.

  • Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another

  • Occasional: Push/Pull: Exerting force to move objects away from or toward.

  • Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles

  • Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.

  • Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

Sensory

  • Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.

  • Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.

  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

Job Research

Organization: VICTR Vanderbilt Coord Center 104241

Title: Clinical Research Data Specialist

Location: TN-Nashville-2525 West End Ave

Requisition ID: 1810174

Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.