Under the supervision of the Coordinating Center Manager within the Clinical Trials Shared Recourses Coordinating Center, the Research Services Consultant I supports the clinical research efforts of the Vanderbilt-Ingram Cancer Center by providing regulatory support for our Investigator Initiated Trials, in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and Medical Center policies and procedures. The NCI-designated Vanderbilt-Ingram Cancer Center (VICC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care. VICC provides research resources to its engaged faculty and offers multidisciplinary cancer care to its patients.
In collaboration with the VU Human Research Protections Program, the Research Services Consultant I (RSC I) 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 research and regulatory issues to identify solutions and develop improvement processes. Certified IRB Professional Certification (CIP) and/or Certified IRB Manager (CIM) preferred. Certification may be acquired within the first year of employment. Nursing license and/or CCRA, CCRC, CCRP or RAC certification helpful.
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, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research.
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 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 VU 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 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.
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 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.
The successful candidate must possess the following skills/characteristics: good organizational and time management skills; good oral and written communication skills; analytical and problem-solving skills; ability to multi-task; self-initiative and motivation; teamwork and facilitation skills; excellent customer service skills; and computer proficiency.
* Bachelor's Degree (or equivalent experience) and 4 years experience
* Day Shift/ Exempt Position
* Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 49 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.org/
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 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.
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 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
* Truven Health Analytics: among the top 100 hospitals in the US
* Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
* The Leapfrog Group: grade "A" in Hospital Safety Score
* National Institutes of Health: among the top 10 grant awardees for medical research in the US
* American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
* Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
* Nashville Business Journal: Middle Tennessee's healthiest employer
* American Hospital Association: among the 100 "Most Wired" medical systems in the US
Internal Number: 1911721
About Vanderbilt Health
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 th...e 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.