Develop and coordinate mechanisms to assure compliance with human subject protection guidelines. Coordinate regulatory, data safety evaluation, and protocol development functions for on-site and multiple sites/affiliates. Provide oversight and education to staff involved in research studies. Audit investigator-initiated protocols and data and present findings to regulatory committees. Assist with study feasibility and budget development.
Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.org/
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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.
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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.
Act as liaison of research activities between investigators, agencies, sponsoring companies, regulatory committees and other participants.
Oversees the development of protocols, the overall clinical plan, draft protocols, and coordinates the protocol review and approval process with various committees and staff.
Supervise staff, monitor data, and assign corrective measures for adherence to protocol and regulatory compliance.
Perform ongoing monitoring and evaluation of studies to assure compliance with federal and institutional regulations
Develop and implement auditing programs, policies, procedures, documentation and systems in accordance with Federal, State and University mandates.
Assist in development of research designs, amendments, and evaluations and offers direction in implementation for collection of accurate data evaluation and analysis
Provides advice, guidance, and problem resolution to PI on protocol design/development and data collective mechanisms.
Conducts data analysis and provide written research analysis for project components on a regular bases.
Coordinate protocol submission to the Scientific Review Committee, Radiation Safety Committee, Biosafety Committee, and IRB
Original proposals are created that meet institutional and FDA regulations
New research proposals are prepared and processed according to regulations
Consent forms, amendments, continuing review applications, FDA, IND applications, SAE analysis and reports are prepared and processed according to regulations
Obtain input from local site's IRB representative to assure consideration of local context issues in different demographic regions as applicable
Develop and provide training and staff development on regulatory requirements and protocol design
Develop and deliver training on research protocols to ensure regulatory, and University compliance
Provide training to physicians, nurses, professors, teachers, data collectors, regulatory coordinators, and technicians and other staff involved in research studies in an understandable manner
Educational needs are identified based on audits and other information; develop and deliver training as needed
Provide instruction on the interpretation of test results, and observations
Implement data safety monitoring mechanisms ensuring regulatory standards are met and coordinate reporting to Data Safety Monitoring Committee while assisting with implementation of corrective measures based on findings of audit of studies.
Organizes and performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines
Analyze data and prepare audit reports and summaries, findings are presented to the Committee(s)
Ensure databases to track human subject research are implemented and maintained
Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training with staff development for on-site and off-site personnel as required
Maintain a current knowledge of Federal, State, and University laws, regulations, guidelines governing human subject research
Represents human subject compliance programs on various groups and committees as appropriate
Conducts site visits (travel required)
Prestudy site visits are conducted as required
Evaluative reports are prepared
Site monitoring visits are conducted and followed-up to resolve identified problems
Files, records, case report forms, and source documents are reviewed for completeness, accuracy, and compliance; identifies deficiencies and discrepancies, and remedial training is provided as needed
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.