Research Regulatory Affairs Project Manager - VICTR
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.
3-4 yearsâ experience working in clinical drug trial research
1 year experience working with the IND
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.
Experience in developing an IND strategy and amendments
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.
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.
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.
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Â· The Leapfrog Group: grade "A" in Hospital Safety Score
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Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.