Clinical Research Regulatory Affairs Specialist **REMOTE AVAILABLE**
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2116849
Clinical Research Regulatory Affairs Specialist - VICTR - VCC
Supports clinical research efforts by serving as the central resource to investigators to assist and provide regulatory guidance through experience with and knowledge of related local/state/ federal regulations. Works closely and 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 for studies involving human subjects. This may include study planning, start-up and implementation, Investigational New Drug (IND) applications, drug development, regulatory and compliance issues, and budget development. Participates in training faculty and staff in the research community, as well as the development and revision of educational programs.
About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org .
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Navigates VUMC researchers through operationalizing study start-up, management, and closure.
Prepares, processes and manages all IRB submissions for initial and ongoing approval, adverse event reporting, continuing review and SMART IRB approvals.
Ensures compliance with Good Clinical Practice guidelines (GCP), internal procedures and appropriate regulatory agency guidelines
Provides training to site staff prior to implementation of new trials.
Collaborates and interfaces with Budget Analyst, Institutional Review Board (IRB), Office of Contract Management and Finance to secure adequate funding for Research Trials.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
REGULATORY ACTIVITIES (ADVANCED)
Utilize knowledge of local/state/federal regulations and institutional procedures to serve as a resource accurately and effectively on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, study design, marketing, and HRPP submissions.
Coordinate, prepare and review regulatory submissions/documents to the appropriate regulatory body.
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 (ADVANCED)
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.
May provide ongoing assistance, consultation, and education to research personnel regarding quality assurance audits. 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.
Serve as a resource to the research community to answer questions regarding compliance issues that arise.
SUBMISSION MANAGEMENT (ADVANCED)
Reviews initial submissions to determine review category and action to be taken.
Manages new submissions and continuing review activities.
Completes submission applications, and other required documentation.
prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
Manages identified issues and provides feedback to leadership regarding resolution.
Review material for completeness, internal consistency with other documents, and conformance to applicable agency regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that meet all applicable regulatory requirements.
EDUCATION AND TRAINING (ADVANCED)
Provide regulatory education and training to the research community to promote compliance with the HRPP/IRB policies and procedures.
May 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, and lead and coordinate ongoing training and support for investigators and research staff, as needed.
Collaborate with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support, as required.
Create an environment that encourages and supports development and learning for research personnel through regular feedback.
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.