Healthcare Research Regulatory Affairs Specialist

Healthcare Research Regulatory Affairs Specialist - VICTR

JOB SUMMARY

Serves as the central resource to investigators to assist and provide regulatory guidance through experience with and knowledge of related federal regulations (FDA). 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. 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.

KEY RESPONSIBILITIES

• 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.

TECHNICAL CAPABILITIES

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.

COMPLIANCE (INTERMEDIATE)

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.

About the Department:

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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