Sr. Research Regulatory Affairs Manager - VICTR
JOB SUMMARY :
In your pivotal role as Sr. Research Regulatory Affairs Manager, you will serve as the central resource to investigators to assist and provide guidance regarding Investigational New Drug (IND) development through experience with and knowledge of related federal regulations (FDA). You will work closely and partner with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures and federal regulations. You will provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. In this role you will serve as a resource to investigators to assist and provide guidance and education regarding device development through experience with and knowledge of related federal regulations.
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/ .
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The national Recruitment Innovation Center, located within VICTR at Vanderbilt University Medical Center in Nashville TN, is expanding and as such is seeking an individual with a passion for recruitment of participants into clinical trials. Our team is dynamic and forward thinking in the development of new strategies to help clinical trials recruit and retain individuals, with an emphasis on participant engagement at all levels of the trial development and implementation.
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