Your Role : This position will coordinate all aspects of research regulatory management for the Emergency Medicine Research Division. The position will provide a single point of contact for sponsors, CROs, Investigators, and key study personnel. They will also perform many of the daily regulatory tasks including VA and VUMC IRB preparation, continuing reviews, adverse event reporting and closure, new contract submission, arranging and facilitating PSV, SIV and monitoring visits.
Key functions and expected performances include but are not limited to the following:
1. Division Research Regulatory Management * Assemble and evaluate all materials for each study to determine the appropriate IRB submission type. * Utilizing the protocol and other study documents, prepare and submit all submissions for the VUMC and VA IRBs, including: o initial reviews o amendments o continuing reviews o closures o Adverse Events o noncompliance with the protocol submissions * Develop informed consent document and other study documents for submission to the IRB, within policy and regulation. * Monitor IRB submissions and study status to obtain and maintain timely approval. * Communicate with HRPP staff and IRB Committee members as needed. * Coordinate all single IRB (sIRB) submissions, both as the IRB of record and as a relying site.
2. Research Sponsor Regulatory Management * Participate in all site selection visits, initiation visits, and close-out visits. * Communicate with sponsors or CRO regarding Division and IRB policies. * Provide all IRB correspondence and approvals to sponsors or CRO. * Interface with study monitors during monitoring visits, answering questions and providing updated documents as needed. * Provide complete and accurate essential documents to sponsors or CRO during study start-up. * Collaborate with the Director of Clinical Operations to prepare for site qualification visits, site initiation visits and monitoring visits. * Oversee maintenance of updated CVs, licensure, and GCP training for Investigators and Key Study Personnel (KSP). * Oversee creation and maintenance of regulatory binders for each study.
3. Research Administration Support * Develop and maintain study registrations on clinicaltrials.gov. * Create studies on eSMART, including billing plans. Update as needed. * Utilizing enrollment logs and other documentation, prepare invoices for sponsors. * Regularly complete reconciliations: * Sponsor payments (as needed) * Research charges (weekly) * CORES/iLab charges (monthly) * Prepare and distribute study reports: * Enrollment reports * Privacy Waiver Surveys * Other study specific reports * Train new staff and faculty on regulatory and training requirements * Assist with management of study subject payment methods as needed
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.
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 :
The Institute for Medicine and Public Health at Vanderbilt exists to connect research and teaching with policy and practical solutions. We are charged with re-imagining and amplifying collaborations among more than 50 departments, 292 faculty, 208 staff, 110 graduate students, more than 21 centers, and all ten schools. The Institute reaches across the state, nation, and the global community to translate knowledge into better health.
We currently manage a grant and contract portfolio that exceeds $200 million and spans topics from aging to zoonosis and methods from clinical trials and community-engaged research to bioinformatics and personalized medicine to ethics and policy.
As we grow, we are looking for individuals who are as excited as we are about expanding our research portfolio and achieving even higher levels of service to our investigators so that they can compete well for funding, manage projects efficiently, and make discoveries that advance health.
Our administrative positions manage a portfolio of responsibilities that include budgeting, forecasting, financial reporting, developing grant applications, development of sponsored clinical trials, research administration and compliance, marketing and communication, creating visual presentations, creating infographics, data management and analysis. Our service-delivery model utilizes a team-centric and collaborative approach to provide deliverables, create systems, and develop tools. A focus on relationships and community are essential to the team's success.
For more information, please visit https://www.vumc.org/medicine-public-health/imph-administrative-careers
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
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.