The Healthcare Research Regulatory Affairs Specialist serves as the central resource to investigators to assist with and provide regulatory guidance through experience and knowledge of related federal regulations (FDA). The Healthcare Research Regulatory Affairs Specialist closely partners with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures, and federal regulations. This may include study planning, start-up and implementation, Investigational New Drug (IND) applications, drug development and regulatory issues. Participates in training faculty and staff in the research community, as well as the development and revision of educational programs.
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt's virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center's Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/ .
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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.
Provides consultation to determine if an IND/IDE is needed for proposed research and tracks new and ongoing INDs and IDEs.
Assists researchers with FDA submissions and study design questions, ensures the quality of FDA applications, protocols, submissions and documentation, and maintains Institutional files for all FDA correspondence.
Offers training for protocol development/review, and provides tools, templates, and guidance for obtaining and maintaining an IND/IDE clinical trial.
Navigates VUMC researchers through operationalizing study start-up, management, and closure.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
REGULATORY ACTIVITIES (INTERMEDIATE)
- Utilize knowledge of federal regulations and institutional procedures to accurately and effectively
serve as a resource on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, study design, marketing, FDA submissions, HRPP submissions, and manuscript preparations. Advise investigators on preclinical and regulatory pathway most appropriate for specific IND development. Assist investigators in developing FDA applications and protocols and determining types of regulatory submissions and internal documentation required in diverse situations. Coordinate, prepare and review regulatory submissions/documents to the appropriate regulatory body. Actively support researchers in communications with the FDA by scheduling meetings and preparing and submitting communications per regulations. Identify and assist with interpretation of relevant regulations, guidance documents, and consensus standards. Collaborate, as needed, with other individuals assisting investigators in research activities throughout the Institution. Actively participate in project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes. Interface and partner with regulatory bodies that influence policies and regulations that affect research including the Vanderbilt Human Protection Program, Risk Management, General Counsel, Contracts Management, Office of Sponsored Programs, and Department of Finance.
QUALITY ASSURANCE (INTERMEDIATE)
- Utilize strong working knowledge of federal regulations and institutional procedures to assist investigators in the development of quality metrics and management of an effective quality assurance process to support compliance with federal regulations for methods, facilities, and controls. Provide ongoing assistance, consultation, and education to research personnel regarding quality assurance audits. Clarify data discrepancies and deviations from standard operating procedures. Review and oversee adverse events, protocol deviations, and unanticipated problems to ensure appropriate and timely reporting. Analyze results and assist in the development of a preventive action plan for potential future discrepancies. Design and develop audit measures based on general SOPs and prepare checklists for inspections and compliance monitoring. Perform statistical analyses to identify data discrepancies and to determine error rates/trends. Develop, prepare, and present audit reports, as required.
Collaborate on the development and management of SOPs as well as other documentation according to all applicable regulations. Compile and maintain regulatory documentation databases or systems. Promote compliance through detection, resolution, and reporting of research activities that do not conform to federal, state, and local laws, as well as Institutional policies and procedures. Consult on policy interpretation related to research record privacy and appropriate access to electronic medical records. Remain apprised of changes in regulations and institutional policies that affect research and recommend changes to institutional procedures in response to changes in regulations or standards. Serve as a resource to the research community to answer questions regarding compliance issues that arise.
EDUCATION AND TRAINING (INTERMEDIATE)
Provide regulatory education and training to the research community to promote compliance with the HRPP/IRB policies and procedures. Develop, implement and document meaningful educational activities for the VUMC Research Enterprise in collaboration with team leaders. Assist with the development of customized educational sessions. Lead and coordinate ongoing training and support for investigators and research staff. Collaborate with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support. Create an environment that encourages and supports development and learning for research personnel through regular feedback.
Bachelor's Degree (Required)
2 years' experience (Required)
Advanced degree preferred
Minimum 2 years' experience working in clinical drug trial/IND research
Strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities.
Experience in developing an IND strategy and amendments
Ability to standardize consulting practices across multiple regions in order to streamline efficiencies and improve overall delivery of service while maintaining the highest standards in regulatory compliance.
Ability to establish and maintain relationships with sponsoring companies, investigators and institutional research units to optimize the performance of research activities while managing the activities of investigative sites across multiple protocols and multiple areas.
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.