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.

Organization:

VICTR

Job Summary:

Associate Clinical Research Regulatory Affairs Specialist - VICTR - Vanderbilt Coordinating Center - VCC (Local Support Services)

JOB SUMMARY
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. With oversight, 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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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.

Core Accountabilities:

Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Continuously improves own skills by identifying development opportunities.- Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas. - Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner. Delivering Excellent Services: - Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service. - Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner. - Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support. Ensuring High Quality: - Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.- Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond. - Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department. Managing Resources Effectively :- Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service. - Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources. - Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error. Fostering Innovation: - Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.- Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action. - Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Position Qualifications:

Responsibilities:

Certifications:

Work Experience:

Relevant Work Experience

Experience Level:

Less than 1 year

Education:

Bachelor's

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