Clinical Research Associate 2 - VCC - VICTR
This is a full-time/exempt term position lasting six months to one year.
This position is responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, conduct of research protocols, and data management functions, such that the clinical research is maintained and the integrity and quality of the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure, and research protocols.
About the Department:
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt's virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center's Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care.
VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/ .
View how Vanderbilt Health employees celebrate the difference they make every day:
Ensure compliance with clinical trial protocol, check clinical site activities, make on-site visits, review case report forms (CRFs), and communicate with clinical research coordinators.
Assure the protection of the rights, safety and well-being of human study subjects.
Ensure that the scientific integrity of the data collected is protected and verified and that adverse events are correctly documented and reported.
The responsibilities listed are a general overview of the position and additional duties may be assigned
DATA MONITORING (INTERMEDIATE)
REPORTING & DOCUMENTATION (INTERMEDIATE)
Fully document trial related monitoring, including clinical study progress. Ensure site IRB approval is current and all IRB documentation is in order.
Ensure that all AEs are reported within the required reporting timelines, documented as appropriate, and consistent with all data collected and with the information in the source documents. Promptly communicate relevant status information and issues to appropriate stakeholders. Write and distribute monitoring visit reports and any supplemental documents/reports to all sites for review and approval.
Complete follow-up letter to communicate relevant information and required corrective action to investigators and their teams. Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
QUALITY ASSURANCE (INTERMEDIATE)
PROJECT ADMINISTRATION (INTERMEDIATE)
Discover Vanderbilt University Medical Center:
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
Additional Information :
Drug Information Association Inc