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.
Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's leading children's hospitals. We treat and help prevent all health issues ranging from colds and broken bones to heart disease and cancer.
The world-class facilities at Children's Hospital are a testament to our community's dedication to the health of children. Constructed in 2004 and expanded in 2012, our 271-bed hospital is a child-friendly place built on the science of healing.
A building alone does not make a great hospital. Our exceptional medical teams and the generous support of people like you enable us to provide every child who comes to us with the hope of improved health. Children's Hospital is a nonprofit facility. No child who needs our services is denied care on the basis of limited ability to pay.
Many of our doctors and surgeons are nationally recognized researchers who are finding new ways to cure and prevent childhood diseases. Their work preventing and treating premature birth, cancer, heart disease, spina bifida, and many other conditions is an investment in the future. We are at an important crossroads in child health. Our commitment to research and advocacy positions us to bring the promise of good health to children and families in our community and to share that hope with the world.
Your Role :
Human Subject Research
Proficiently prepares, processes and administers the Division's Human Subject Research · Creates the Investigator's IRB Protocol utilizing Discovery-E. · Submits IRB amendments (changes in Protocol, Consent Form, Data Collection Forms, etc.) · Compiles the IRB Continuing Review Applications – progress report on the active human subjects research study – is it still actively enrolling, will it continue, any adverse effects/problems, any discoveries, etc. · Reports adverse events to the IRB according to the institutional and departmental policies and procedures and federal regulations (Problems that occurred during the human subject study).
Partners with the Division's Investigator(s) in compiling their IRB – new, amendment (changes), and associated documents (Consent Forms, IND, etc.)
Liaison between the Division, regulatory agencies, funding sponsors, and Vanderbilt/VUMC departments/divisions, and research sites. Compiles and disseminates the information to the investigators, Division Director, and AOs that was acquired from engaging the various institutions.
Supports the Division's investigator in acquiring the appropriate research documentation in sharing research data and/or research materials with non-VUMC Sites by executing a Materials Transfer Agreement (M-Share) and/or Data Sharing Agreements via PEER.
b. Assists the Division's Investigators in reviewing and procuring clinical trials/research funding opportunities that would support their scientific work (Utilize Federal, Non-Federal, Foundation, VUMC Internal Grant Links and identify the best match for the investigators).
c. Acquires the appropriate Sponsor's Confidentiality Agreement (Utilizes PEER) in order to obtain the Sponsor's Protocols for the proposed clinical trial. Reviews the protocol and meets with the investigator to discuss the scope of managing this study's research protocol. Thus aiding the investigator in his/her decision to either accept or reject the Sponsor's proposed clinical trial.
d. Teams with the Investigator, Research Nurse/Research Coordinator, and Research AO in reviewing the Sponsor's proposed clinical trial contract. The review of the sponsor's contract will provide the outline on how the study is to be managed, how it is funded, publishing results, etc. This will further assist the Investigator on their decision to accept or reject the Sponsor's Contract. PEER will be used to submit the contract to the VUMC Office of Contracts
e. Compiles the necessary clinical trial documents (Confidentiality Agreement, Contract, IRB, Protocol, Investigator's Brochure, etc. and submits them in eSMART. These documents need to be uploaded in eSMART in order for the VUMC Contracts Office to execute the Sponsor's Contract.
f. Participates with the investigator and research nurse in periodic site visits conducted by the sponsor (on-site study review/audits). Ensures that all regulatory documents (IRB, Protocol, Data Collection Forms, etc. are current and maintain in accordance with the Sponsor's Study Guidelines).
g. Maintains open and positive communications with investigators, co-workers, other departments and sponsors.
Research Support for Grant Submission
a. Submit Confidentiality Agreements and Contracts to VUMC Contracts Division via PEER.
b. Creates the eSMART Project (VUMC's Research Management System) by utilizing the various clinical trial documents (Confidentiality Agreement, Contract, IRB, Protocol, Investigator's Brochure, etc.).
c. Produces the Billing Intention Plan based upon the payment milestones from the Sponsor's executed Contract for the investigators clinical trial in eSMART.
d. Creates Grant Applications (compiles Biosketches, Letters of Support, Research Strategy, etc.) and submits them by utilizing the VUMC COEUS System.
e. Create, acquire, and maintain documents such as biosketches, Letters of Support, Equipment, Narrative, Other Support, etc. needed for new and/or grant renewals.
f. Collaborate with PI and AO, in providing information (biosketches, Letters of Support, Equipment, Narrative, etc.) needed for timely Grant preparation and submission.
Budgetary Responsibilities for Research Cost Centers
a. Create and submit invoices (invoices are based upon the Sponsor's Payment Milestones/Milestones are confirmed by the Investigator and/or Research Nurse/Coordinator) for the various clinical trials for the Divisions investigator.
b. Assist the Investigator, Research Nurse/Research Coordinator, and Research AO in the fiscal administration of the Clinical Trials/Research Studies. This is done by ensuring that all milestones, startup fees, etc. have been billed and paid by the sponsor, producing enrollment projections in order to make sure the investigator is on track in meeting his/her recruitment goal, and reviewing the study costs incurred with the investigator and/or research nurse to make sure it correct and appropriate.
c. Compile and complete the monthly purchasing and ledger review reconciliation for all research cost centers.
d. Procures quotes and orders of all high-level kits, chemicals, and various research supplies in accordance with the project's budget.
e. Creates and submits the various non-personnel encumbrances - 1180s, Purchase Requisitions, Check Requests, subject participation, travel expenses (Concur), etc.
f. Produce various financial reports, journal entries, and other ad hoc reports as needed.
a. Supervise research staff in the division, monitoring time and attendance. Reviews and administers their time utilizing Kronos.
b. Coordinate and facilitate performance management annually or as needed for research and admin staff.
c. Assist the Division Director and Investigators in the procurement of Research Nurse(s), temporary research staff, students/summer students in order to support their various research studies.
a. Posters, Presentations, and Written works for Division Chief
· Generates various academic and professional written products for the Division Chief and Faculty Members: such as Faculty and Fellow Letters of Recommendation; Letters of Support; Letters in Support of T32 and other Research Grant Opportunities; Sections that will be presented/used in our division's business plan and annual reports; Sections that have been used in Grant Submissions; book foreword for a book by Ute Navidi; various ad-hoc reports of scholastic/academic activities as needed
· Create and produce posters & graphic presentations as requested: generated scientific posted for division chief's research project to be presented at the DDRC Pilot Grant (funded 2 years in a row); produced Power-point presentation for Dr. Acra – used in presenting the 2015 Shwachman Award to D. Brent Polk during the National NASPGHAN Conference; produces posters & handouts for the annual Pediatric Cumberland Foundation conferences; produces/creates other presentations as needed for the division chief.
· Prepares meeting agendas; drafts letters of invitations to potential board members and guest-authors; suggests topics of interest to use in publications; assists in researching potential guest-authors; meets weekly with our Editorial Office in Belgrade.
c. Communicate, implement, interpret, and revise research policies and procedures as appropriate (Division's Clinical Trial Policy, Grant Research Policy, etc.)
Bachelor's Degree (or equivalent experience) and 3 years relevant experience
Days / Variable
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 ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
· Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
· 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
· Magnet Recognition Program: Vanderbilt nurses are the only group honored in 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.