Associate Clinical Research Regulatory Affairs Specialist **REMOTE AVAILABLE**
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2202588
Associate Clinical Research Regulatory Affairs Specialist - VICTR - Vanderbilt Coordinating Center - VCC **REMOTE AVAILABLE**
The Associate Clinical Research Navigator (CRN) is the primary resource, providing personalized, expert assistance to internal Vanderbilt faculty and staff members as well as to external research sponsors, for a very diverse platform of clinical research projects. This position will be housed within the Vanderbilt Institute for Clinical and Translational Research (VICTR), specifically within the Vanderbilt Coordinating Center (VCC) for clinical and translational research. The CRN 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 CRN 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 CRN 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.
Serve as a central resource for investigators to provide expertise, guidance and education on investigator initiated clinical trials.
Provide navigation through institutional practices, policies and workflow.
Maintain a working knowledge of institutional committees and centers
Advise and assist investigators on proper protocol development to adhere to regulatory guidelines.
Maintain a working knowledge of Federal mandates, GCP/ICH guidelines, IRB policies and procedures.
Assist with development and/or adherence to efficient and reasonable deadlines.
Analyze and assist with budget development, securing funding from external sponsors, and ensuring ongoing financial compliance.
Advise and assist with the creation of data management tools and record keeping practices.
Advise investigators on efficient recruitment efforts.
Serve as a liaison between investigators and external customers.
Advise investigators on protocol feasibility.
Advise external customers on institutional practices, policies and workflow.
Serves as the central resource for the research community to provide expertise and guidance on issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Participates in institutional activities regarding culture and regulatory issues related to research.
Monitors and analyzes new legislation, federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community.
Provides expertise to departments, institutional committees, investigators, research staff, and students on procedures and operating practices for the research community on human research protections and good clinical practices.
Establishes and maintains communication with investigators, research staff, and representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human subjects participation in research.
Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
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 time lines 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.
Analyzes cost estimates and budget requests developed for planning and projecting human research protections program activities.
Assists with the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.
Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise.
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.
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.
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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* US News & World Report: #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
* Magnet Recognition Program: Received our third consecutive Magnet designations.
* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
* Human Rights Campaign Healthcare Equality Index: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
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.