Responsible for the timely preparation, planning and quality control of regulatory documents required for human subjects research under occasional guidance. Coordinates review by Institutional Review Board of research proposals/protocols.
Department/Unit Summary:
At the Vanderbilt Eye Institute, we strive to make life better for adults and children with eye conditions including glaucoma, vision loss and diseases of the retina. We treat patients from across Tennessee and the Southeast. Our doctors, researchers and support staff use the latest technologies and methods, and we conduct vital vision research that translates to better treatments.
The Vanderbilt Eye Institute is a leader in quality eye care. We offer the latest technologies and methods while conducting innovative research to improve patients' lives and prevent vision loss.
We work hard each day because your eyes are important to us.
The Vanderbilt Eye Institute attracts some of the most talented doctors and researchers in the country. Our subspecialty ophthalmologists have completed a minimum of one year of fellowship training after residency and are board eligible or board certified by the American Board of Ophthalmology.
Vanderbilt Eye Institute's award-winning research staff collaborates with our doctors as well as other Vanderbilt departments to pursue discoveries that enhance the vision of patients everywhere.
Position Shift:
First Shift
View how Vanderbilt Health employees celebrate the difference they make every day:
Discover Vanderbilt University Medical Center:
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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Additional Key Elements/ Responsibilities:
Coordinate protocol and patient consent form process
Compile and analyze protocol information necessary to write IRB proposals and patient consent forms
Formulate, design, and revise research proposal forms which are to be completed by research investigators who intend to do research involving human subjects; serve as a resource to these investigators and others who are engaged in research and/or undergoing audits.
Write consent forms, conferring with PI and/or sponsor on language required. Ensure compliance with federal/IRB regulations
Review proposals for completeness of preparation and presentation of adequate and appropriately related information
Communicate and coordinate with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
Compose and submit Investigational New Drug Applications to the FDA for drugs needing FDA approval. Inform FDA of all revisions to the study and obtain IRB approval of revisions.
Supervise clerical support staff to ensure that records and files are properly maintained and that the appropriate documentation is obtained when required
Maintain database to track protocols, NCI registration, amendment renewals, new submissions, approvals, INDs, outside safety reports, adverse event forms and other data necessary to ensure compliance with regulatory guidelines.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES:
RESEARCH ADMINISTRATION (INTERMEDIATE): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
MEDICAL RECORDS MANAGEMENT (INTERMEDIATE): Knowledge of how and where to store and maintain basic records associated with job assignments.
LABORATORY PRACTICES (INTERMEDIATE): Demonstrates mastery of laboratory practices in practical applications of a difficult nature. Possesses sufficient knowledge, training, and experience to be capable of successfully delivering products and services using laboratory practices without requiring support and instruction from others. Able to train and educate by setting the example, giving technical instruction, providing leadership, and generally raising the level of performance of others while on the job.
CORE ACCOUNTABILITIES:
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.
CORE CAPABILITIES:
SUPPORTING COLLEAGUES:
Develops Self and Others: Invests time, energy and enthusiasm in developing self/others to help improve performance and gain knowledge in new areas.
Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.
Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences.
DELIVERING EXCELLENT SERVICES:
Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.
Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.
Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness.
ENSURING HIGH QUALITY:
Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.
Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them.
Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring.
MANAGING RESOURCES EFFECTIVELY:
Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.
Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.
Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities.
FOSTERING INNOVATION:
Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.
Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.
Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.
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.
