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.
About the department: Human Research Protection Program Mission
Protecting the safety, rights and welfare of human research participants through:
Collaboration – with Investigators, key study personnel, other supporting institutional bodies and external entities towards a common goal of protecting human research participants.
Service – guiding and supporting the development of research based on sound research design and strong ethical principles that contribute to scientific and scholarly advances in behavioral, social, biomedical and other sciences.
Developing and Implementing human research protections education programs on the application of IRB policies and procedures, and Federal regulations and guidelines.
Continuing education of Investigators and key study personnel resulting in an up-to-date and knowledgeable research community in human research protections, regulations and institutional policy and procedures.
Consulting with Investagors and key study personnel in the development of research programs to facilitate compliance with regulations, and assuring adherence to FDA and other regulatory guidelines, ethical considerations and institutional policies related to human research protections.
Administer a Community Outrearchy Program that serves the Nashville community for education on the rights of research participants.
Providing an Outreach Program for the Vanderbilt Community to educate them on the Federal regulations and human research protections.
Quality – Post Approval Monitoring of human research activities to assure compliance with Federal regulations, VHRPP and institutional policies and procedures.
Supporting a continuous quality improvement program through continuous assessment, evaluation and action.
JOB SUMMARY : Review and track new research proposals, continuing review of existing research protocols, adverse event reporting and database management of all research protocols involving human subjects.
Your Responsibilities :
Independently performs comprehensive pre-review and processes new research proposals, amendments, continuing review applications and adverse events preceding IRB Committee meetings, according to institutional/departmental policies and procedures and federal regulations.
Proficiently facilitates and documents IRB Committee Meetings according to institutional and departmental policies and procedures and federal regulations.
Accurately documents key concepts and captures detail of controverted issues discussed during committee meetings as required by federal regulations. Able to differentiate between major and minor issues raised during discussions.
Proficiently processes and follows up of new research proposals, amendments, continuing review applications and adverse events succeeding IRB Committee Meeting according to IRB policies and procedures and federal regulations.
Provides training and acts as internal consultant to staff, committee members, and the VU research community. Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance own professional development.
Effectively applies analytical/problem solving skills and continuous quality improvement (CQI) tools and methods in daily work activities.
Recognizes and accepts additional responsibilities to support team/department by covering absences, assisting with increased workloads, sharing expertise and specific knowledge with team/coworkers, preparing for scheduled absences and delegating appropriately, following departmental/institutional policies on absences and leaving early.
** Required Minimum Qualifications **
Bachelor's Degree (or equivalent experience) and 2 years experience
In addition to offering a lively community that encourages learning and celebrates diversity, Vanderbilt University Medical Center provides its faculty and staff members with a benefits package that is comprehensive and flexible. Components for benefits-eligible employees include:
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 disea...se.
As the 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.