Associate Clinical Research Data Monitor(Remote Opportunity) - VICTR - Vanderbilt Coordinating Center (VCC)
Requisition # 1907473
Bachelor's Degree (or equivalent experience) and 5 years of experience
This is a full-time/exempt term position lasting six months to one year and may have the opportunity to work remotely!
In your pivotal role as an Associate Clinical Research Data Monitor, 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.
* - Correctly and efficiently performs basic source data verification checks for primarily basic (low risk) studies
* - Maintains effective working relationships with study team, study PI, and participating sites. Consults with other VCC employees to solve operational or data problems. Provides reports to the applicable Clinical Trial Operations Manager.
* - Assists with the assessment of a project's status, task completion, and staff productivity in order to keep study milestones on track. Determines status of incoming data, site responsiveness, need for the development of a customized action plan in order to address and prevent issues, and the need for additional support from leadership within the VCC, other VUMC departments, or within the external participating sites in order to solve outstanding issues.
* - Generates data retrievals and summaries and performs data analysis as needed for Clinical Trial Operations Managers, study Principal Investigators, Steering Committees, Safety Monitors, and for Data Safety Monitoring Boards.
* - Validates clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
* - Possesses an eagerness to learn about the many diverse therapeutic areas, both surgical and medical as well as adult and pediatric, supported by the VCC.
* - Reviews electronic case report forms for completeness and consistency.
- Queries data inconsistencies and revises case report forms in compliance with standard operating procedures as needed. Reviews and approves post production changes to active study databases in order to control study documentation and workflow.
* - Prioritizes work in line with project management decisions.
* - Maintains a thorough understanding of clinical data management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
* - May attend internal and external project meetings in order to provide input from a CRDS perspective. May provide input to the study PI and sponsor as needed when issues surrounding data management are negatively impacting a study's progress.
* - Possesses the ability to understand clinical research participant interaction and may serve as a resource to participating site personnel.
Additional Information :
This is a term position. A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. This position may also have the opportunity to work remotely.
About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org .
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
Internal Number: 1907473
About Vanderbilt Health
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.