Associate Clinical Research Regulatory Affairs Specialist

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 diverse 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. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and 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.

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KEY RESPONSIBILITIES

• 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.
• Collaborates with sponsors and departments to develop budgets based on protocol requirements
• Collaborates and interfaces with physicians and sponsors to determine study requirements for individual projects

TECHNICAL CAPABILITIES

REGULATORY ACTIVITIES

• 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

• 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.

COMPLIANCE (Novice)

• 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 (Novice)

• Reviews initial submissions to determine review category and action to be taken.
• With oversight, 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 (novice)

• 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.

BASIC QUALIFICATIONS

Bachelor's or equivalent experience required

Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more.

At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose.

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Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled