West Ashley, SC
Valhalla, New York
Mt. Pleasant, SC
North Charleston, SC
Great Falls, Montana
Maple Grove, Minnesota
Location: Nashville, Tennessee
Internal Number: 2113835
Associate Clinical Research Regulatory Affairs Specialist - VICTR - Vanderbilt Coordinating Center - VCC
This is a full-time/exempt term position lasting six months to one year.
The Associate Clinical Research Regulatory Affairs Specialist (CRRAS) supports clinical research efforts by serving as the central resource to investigators to assist and provide regulatory guidance through experience with and knowledge of related local/state/ federal regulations. 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 for studies involving human subjects. The Associate CRRAS advocates for researchers and study coordinators, identifies barriers to optimal study execution, formulates, implements, and assesses solutions to those barriers, identifies resources needed for the timely & successful completion of research projects, refers investigators to appropriate clinical research services and/or cores within or outside of the Vanderbilt community, consults on and provides input to institutional polices, and identifies and promotes clinical research best practices. This position initiates, develops, and maintains relationships with key central research contacts within various offices in order to facilitate the timely and proper initiation and ongoing operation of clinical research projects overseen by the VCC. The Associate CRRAS knows who to contact and where to seek answers when investigators have questions about preparing grant proposals, identifying study funding, ongoing financial management, Medicare Coverage Analysis, contract negotiations, safety committees, IRB submissions, scientific review submission, study feasibility, recruitment methods, data management, and study implementation. The Associate CRRAS is also responsible for tracking the progress of clinical research protocols through each step of the regulatory/administrative process and following up as necessary to ensure efficient service.
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 .
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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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
* Magnet Recognition Program: Received our third consecutive Magnet designations.
* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
* Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
PROJECT MANAGEMENT (NOVICE)
REGULATORY ACTIVITIES (NOVICE)
QUALITY ASSURANCE (NOVICE)
Develops and implements quality assurance and regulatory plans/projects for the - research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements and recommends activities and resources required to support them.
SUBMISSION MANAGEMENT (NOVICE)
EDUCATION AND TRAINING (NOVICE)
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.