Description
Research Regulatory Affairs Project Manager - VICTR
Your Role
The Research Regulatory Affairs Project Manager 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). The Research Regulatory Affairs Project Manager works closely and partners 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. Provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. 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.
Position Qualifications
Required:
- PhD preferred
- 3-4 years' experience working in clinical drug trial research
- 1 year experience working with the IND
Preferred :
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Strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities.
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Experience in developing an IND strategy and amendments
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Ability to standardize consulting practices across multiple regions in order to streamline efficiencies and improve overall delivery of service while maintaining the highest standards in regulatory compliance.
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Ability to establish and maintain relationships with sponsoring companies, investigators and institutional research units to optimize the performance of research activities while managing the activities of investigative sites across multiple protocols and multiple areas.
Department/Unit 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.
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.
Click Here To View The VUMC Promise of Discovery
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
*CA
*IND000
*NHCN
