Job Summary: This position will coordinate all aspects of research regulatory management for the Emergency Medicine Research Division. The position will coordinate sponsor and monitor visits, manage research regulatory documents, coordinate research participant payments, maintain research metrics and provide administrative and program support to the Division. Key responsibilities will include but are not limited to the following:
Division Research Regulatory Management * Provide Sponsor management including: o Schedule Sponsor and monitor site visits (site qualification, site initiation, monitoring, and close-out visits). o Act as the Sponsor and monitor point of contact throughout each study. o Initiate and manage monitor access to the electronic health record (EHR), knowing when to request, extend, and terminate access. o Utilize enrollment records to reconcile Sponsor payments and communicate with sponsors to ensure timeliness and accuracy of payments. * Manage research regulatory documents o Communicate with sponsors or CRO regarding Division and IRB policies. o Interface with study monitors during monitoring visits, answering questions and providing updated documents as needed. o Provide complete and accurate essential documents to sponsors or CRO during study start-up. o Collaborate with the Director of Clinical Operations to prepare for site qualification visits, site initiation visits and monitoring visits. o Oversee maintenance of updated CVs, licensure, and GCP training for Investigators and Key Study Personnel (KSP). o Oversee creation and maintenance of regulatory binders/databases for each study.
Research Administration * Manage research participant payments o Monitor and reconcile gift cards provided to research subjects for participation. o Initiate check requests provided to research subjects for participation. o Collaborate with study Investigator and Director of Clinical Operations to determine the correct amount to use when requesting to open a study petty cash account. o Monitor enrollment to know when to request closure of study petty cash accounts. o Regularly create requests to replenish study petty cash accounts. * Manage study specific clinical research charges o Perform weekly and monthly clinical charge reconciliations. o Monthly reconcile CORES and iLab invoices for clinical charge reconciliations. o Create and maintain study billing plans in eSMART.
Reporting/Metrics * Create and maintain listing of Division publications. Collaborate with faculty to update CVs and the list no less than annually. Report number of publications as needed. * Create and maintain listing of Division awards and honorifics, reporting annually. * Reconcile quarterly department metrics.
Research Division Administration Support * Plan and execute Division meetings, events, and conferences, including: o Scheduling space o Planning meals and arranging catering o Assist with agenda planning and event execution * Maintain Division environment including: o Initiate and track plant service requests and supply orders. o Manage incoming and outgoing mail and shipping needs o Maintain Division marketing via promotional items, bulletin boards, and social media/website. o Assist faculty with Concur submissions
Minimum Requirements: This position requires a Bachelor's degree and a minimum of one year of related experience. Experience with clinical trials is strongly preferred.
Additional Information: This is a full-time position, M-F; 40 hours per week.
Salary is dependent upon education and experience.
Background screens will be performed and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
Department Summary :
Vanderbilt University Medical Center's Department of Emergency Medicine is a national leader in emergency care research. Led by 8 core faculty and an extensive research infrastructure, we are top leaders in designing innovative ED-based research and are top enrollers in both industry and federally funded studies. Our research staff actively screens patients over 100 hours each week in the emergency departments at VUMC and the Tennessee Valley VA Nashville Hospital. Combined, these EDs see over 100,000 patients per year. To ensure timely enrollment in therapeutic studies, the research faculty are immediately available to assist the student team on a daily basis. For more information, please visit https://vanderbiltem.com/em-research .
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 ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
* Truven Health Analytics: among the top 100 hospitals in the US
* 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
* American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
* 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
Internal Number: 2000749
About Vanderbilt Health
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 th...e 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.