JOB SUMMARY: Performs project management support and analysis under occasional guidance. Works with customers to understand and analyze operational procedures, requirements, processes and/or other needs to bring about successful completion of the project. Provides project management support for the Center for Precision Medicine ( www.vumc.org/cpm/ ) in the Department of Biomedical Informatics ( https://www.vumc.org/dbmi/ ). In addition to providing administrative support for Center activities, major responsibilities will consist of management of a federally-funded multi-institutional pragmatic clinical trials network including managing trial activities and assuring the integrity and quality of the research.
About the Center/Department:
The Center for Precision Medicine (CPM) at Vanderbilt University is a multidisciplinary team consisting of basic research investigators, clinicians, data scientists, application developers and support personnel whose objective is to build a research platform that amasses, extracts and curates meaningful information from patient healthcare records and integrates it with genetic information derived from a DNA repository patterned after BioVU. The CPM develops and applies advanced bioinformatics tools to identify genotype/phenotype associations and genotype/treatment relationships in order to facilitate discovery and signally improve healthcare outcomes through the personalization of diagnostics, treatment and disease prevention. For more information, please visit https://www.vumc.org/cpm/ .
The mission of the Vanderbilt Department of Biomedical informatics has complementary themes that include education, research, service, and a commitment to our colleagues in our own institution and around the world. The Educational Mission is to educate undergraduate, graduate, and postgraduate trainees in the theory and practice of biomedical informatics. The Research and Service Mission is to develop and evaluate innovative technologies for the storage, retrieval, dissemination, and application of biomedical knowledge, in order to support clinical practice, biomedical research, life-long learning, and administration and as a result, to contribute to the professional body of knowledge in the field of biomedical informatics. The Professional and Ethical Mission is to maintain cooperation and collegiality with all those who learn and work with us locally, nationally, and internationally; and, to develop and disseminate ethical and professional standards for the conduct of biomedical informatics research and for the use and evaluation of health care informatics applications.
Day Shift/ Exempt Position
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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.
Additional Key Elements/ Responsibilities:
KEY RESPONSIBILITIES FOR CENTER FOR PRECISION MEDICINE ADMINISTRATIVE SUPPORT
Plans, develops, leads and executes the project in order to meet established goals, objectives and timelines.
Provides professional and/or technical leadership in the execution of day-to-day project activities.
Communicates within and across area(s) to maximize information sharing around progress, needs, interdependencies and/or accomplishments.
Facilitates the identification of gaps in service level/processes to identify potential areas for improvement.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
Key responsibilities for management of multi-institutional pragmatic clinical trials network
Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
With oversight from the Office of Contracts Management, facilitates the subcontracting process between Vanderbilt University and participating Clinical Trial sites.
Troubleshoots recruitment problems, reporting problems and works with research coordinators and investigators at participating institutions to ensure compliance with project standards.
Responsible for establishing consistent methods for study communication in an effort to keep project on track, foster collaboration, improve communication, and continually gather support from participating institutions.
Assists with progress report submissions to funding source and/or Program Director
Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.
Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment.
Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.
Team Interaction: Provides informal guidance and support to team members
* Bachelor's Degree (or equivalent experience) and 3 years experience required.
**Masters or PhD in scientific field (Preferred)**
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.