JOB SUMMARY: In collaboration with the VU Human Research Protections Program, the Research Services Consultant II (RSC II) assists with the optimal application of the Federal, State, and local laws, guidance documents, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VU research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The RSC II researches topics of departmental, institutional or strategic importance.
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Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of 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. It is a place 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.
VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
* 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.
KEY RESPONSIBILITIES:
Serves as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Participates and leads 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.
Interfaces and partners with regulatory bodies who influence policies and regulations that affect research.
Establishes and maintains communications with institutional committees, Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research.
May represent the research community on various advisory and operating committees, as appropriate.
Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
Advises and assists the Investigator, 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 capture all study costs and compliance with regulations; and assures 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 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 strategies for the VU research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements, and recommends to the appropriate departmental officials activities and resources required to support this strategy.
Defines, establishes, and assures compliance with all internal 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 standing operating procedures. Analyzes results and assists in the development of a preventive action plan for potential future discrepancies.
Designs and develops 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.
Promotes compliance through detection, resolution, and reporting of research activities that do not conform to Federal, State, and local laws, Institutional policies and procedures.
Performs statistical analysis to identify data discrepancies and to determine error rates/trends; develops, prepares, and presents audit reports, as required.
Responsible for the comprehension, management, and facilitation of IRB regulatory assurance(s), contracts, agreements, and IRB policies and procedures.
Monitors and reports developments regarding Federal, State, and local laws, and research enterprise policies and procedures that impact institutional initiatives.
Manages and develops effective working relationships with customers by seeking, interpreting, and responding to feedback. Contributes to developing standards of conduct and feedback methods.
Monitors the development, approval, periodic review, revision, interpretation, version control, and historical archival to prevent inconsistencies and discrepancies of VU research community, programs, and departmental procedures, assurances, contracts, and agreements.
Develops, implements, and documents meaningful educational activities for IRB Staff, IRB Committee Members, VU Administration, and VU Principal Investigators in conjunction with Team Leaders. Responsible for creating and implementing IRB professional development plan and budget.
Assists and provides guidance for the research enterprise with budget development, analysis, financial risk assessment, billing compliance, and grant writing support in adherence to regulatory requirements.
Assists investigators with developing effective tools to successfully conduct a research protocol analysis related to study costs and risk assessment.
Assists with the performance of Medicare Deemed (all applicable criteria met) trial assessment.
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 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.
Takes responsibility for mistakes or bad decisions and learns from mistakes.
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.
Effectively participates and leads 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.
TECHNICAL CAPABILITIES:
CORE ACCOUNTABILITIES:
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.
Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment.
Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.
Team Interaction: Provides informal guidance and support to team members.
CORE CAPABILITIES:
SUPPORTING COLLEAGUES:
Develops Self and Others: Invests time, energy and enthusiasm in developing self/others to help improve performance and gain knowledge in new areas.
Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.
Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences.
DELIVERING EXCELLENT SERVICES:
Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.
Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.
Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness.
ENSURING HIGH QUALITY:
Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.
Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them.
Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring.
MANAGING RESOURCES EFFECTIVELY:
Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.
Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.
Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities.
FOSTERING INNOVATION:
Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.
Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.
Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.
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.
