Associate Clinical Research Regulatory Affairs Specialist
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2113835
Associate Clinical Research Regulatory Affairs Specialist- VICTR - Vanderbilt Coordinating Center - VCC
This is a full-time/exempt term position lasting six months to one year.
The Associate Clinical Research Regulatory Affairs Specialist (CRRAS) 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. The Associate CRRAS advocates for researchers and study coordinators, identifies barriers to optimal study execution, formulates, implements, and assesses solutions to those barriers, identifies resources needed for the timely & successful completion of research projects, refers investigators to appropriate clinical research services and/or cores within or outside of the Vanderbilt community, consults on and provides input to institutional polices, and identifies and promotes clinical research best practices. This position initiates, develops, and maintains relationships with key central research contacts within various offices in order to facilitate the timely and proper initiation and ongoing operation of clinical research projects overseen by the VCC. The Associate CRRAS knows who to contact and where to seek answers when investigators have questions about preparing grant proposals, identifying study funding, ongoing financial management, Medicare Coverage Analysis, contract negotiations, safety committees, IRB submissions, scientific review submission, study feasibility, recruitment methods, data management, and study implementation. The Associate CRRAS is also responsible for tracking the progress of clinical research protocols through each step of the regulatory/administrative process and following up as necessary to ensure efficient service.
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 IRB submissions for participating trial sites from initial and ongoing approval, adverse event reporting, continuing review and SMART/Single 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.
PROJECT MANAGEMENT (NOVICE)
Develop and communicate appropriate project documentation, including project overview, scope, team structure, status reports, issues management reports, change control reports, meeting notes, etc. as required in a timely manner. Coordinate and lead project team and work group meetings, as required. Manage and communicate project status to team members and executive staff, including management of status reporting and presentations. Identify, document, and manage project issues and escalate, as appropriate, to achieve timely resolution. Ensure compliance with regulatory agencies including meeting deadlines, when applicable.
REGULATORY ACTIVITIES (NOVICE)
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 (NOVICE)
Analyze results and assist in the development of a preventive action plan for potential future discrepancies.
Develops and implements quality assurance and regulatory plans/projects for the - research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements and recommends activities and resources required to support them.
Defines, establishes, and assures compliance with all internal and external standard operating procedures consistent with Federal standards for designing, conducting, recording, and reporting research within the Research Enterprise.
Provides ongoing assistance, consultation, and education to research personnel regarding quality assurance audits; clarifies data discrepancies and deviations from both research and standing operating procedures.
Assists with the design and development of audit measures based on general standard operating procedures and prepares checklists for inspections and compliance monitoring.
Conducts internal and external audits of research at periodic intervals to identify and analyze data errors, data discrepancies, process errors, and deviations from study protocols to assure compliance with applicable regulatory requirements and standard operating procedures.
Analyzes results and assists in the development of a preventive action plan for potential discrepancies.
Collaborate on the development and management of SOPs as well as other documentation according to all applicable regulations.
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)
Advises and assists investigators, key study personnel, and other team members in the development of data tools, record keeping, study budgets, process improvement plans, and efficient timelines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols, as appropriate.
Guides Investigators and key study personnel in the development of protocols and study budgets to facilitate capture all study costs and compliance with regulations; and assure adherence to FDA and other regulatory guidelines.
Develops and implements training programs on the strategic application of IRB policies and procedures, Federal mandates, and guidelines, NIH, GCP/ICH guidance, and other applicable topics (e.g., budget development, research billing, grants, contracts, COI) for the VU Human Research Protections Program.
Critically analyzes current research practices and policies through observation, data collection, peer reviews, interviews, and industry analysis to assess quality of existing workflow processes and identify improvements needed to maximize quality and efficiency of the human research protections programs.
Assists with the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.
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.
Actively demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.
Communicates and models values and mission of VUMC.
Exhibits personal integrity and respect for others.
Treats all team members as unique individuals with valuable resources and skills that enhance the team.
Collaborates with internal and external customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
Assures self-goals are aligned with departmental goals for success.
Accepts responsibility for improvement of one's performance through recognition of strengths and weaknesses, participation in professional development activities, and positive input in team growth.
Actively participates in project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvement.
Takes responsibility for mistakes or bad decisions and learns from mistakes.
This is a term position. A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. This position may also have the opportunity to work remotely.
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.