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.
Under the supervision of the Coordinating Center Manager, the Research Services Consultant III (RSC III) assists with the implementation and management of VICC Sponsor-Investigator Trials. The incumbent will help provide guidance on Federal, State, and local laws, as well as Clinical Trials Office (CTO) policies, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VICC mission goals. The incumbent will serve as the subject matter expert on the complex project management, research, and regulatory issues regarding the start-up and maintenance of the diverse portfolio within the Coordinating Center.
In addition, the RSCIII serves as the initial liaison to funders, governing agencies, and other research entities as needed by facilitating transmission of verbal and written communication. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team meetings, interacting with sponsoring agencies including National Cancer Institute, as well as compliance and regulatory groups such as the Institutional Review Board (IRB) and Food and Drug Administration (FDA).
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 51 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/
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: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Additional Key Elements/ Responsibilities:
Serves as the central resource within the Coordinating Center to provide authoritative expertise and regulatory guidance on complex issues including but not limited to protocol development, and multi-site activation and study maintenance.
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 authoritative expertise to departments, institutional committees, Investigators, research staff, monitors, and auditors operating practices for the research community on human subjects protections and good clinical practices.
Establishes and maintains communications with institutional officials, institutional committees, Investigators, research staff, and representatives of professional organizations
Collaborates with internal and external members of the research community to develop and evaluate services for the improvement of the maintenance of multi-site research protocols.
Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budget, 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.
Confers with 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 VU and VICC policies and procedures, Federal mandates and guidelines, NIH, GCP/ICH guidance, and other applicable topics that impact the management of Sponsor-Investigator trials, with a focus on multi-site trials.
Analyzes cost estimates and budget requests developed for planning and projecting human research protections program activities.
In partnership with appropriate personnel, develops, and implements standard organizational-wide guidelines and documentation requirements.
Defines, establishes, and assures compliance with all internal standard operating procedures consistent with standards for designing, conducting, recording, and reporting clinical trials; assists functional group directors and staff in the development of standard operating procedures.
Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for all research programs within the Research Enterprise.
Develops and implements quality assurance and regulatory strategies for the Coordinating Center to assure compliance with all applicable requirements; interprets regulatory requirements and recommends to the appropriate institutional 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.
Designs and develops quality assurance measures based on 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.
Negotiates contractual agreements and party responsibilities in accordance with Federal, State, and local laws, institutional policies and procedures, and Federal-Wide Assurance.
Monitors and reports developments regarding Federal, State, and local laws, and institutional policies and procedures that impact Research Enterprise 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.
Provides guidance on program size, scope, and complexity in relation to overall budget size, funding sources, impact to the institution, adequate staff, and facilities which support the program, customers served or services being performed/delivered.
Develops, implements, and documents meaningful educational activities for Coordinating Center Staff, participating sites, and VU Investigators.
Assists investigators with developing effective tools to successfully conduct a research protocol related to study cost and risk assessment.
Actively demonstrates facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling.
Communicates and models values and mission of VUMC. Exemplifies personal integrity and respect for others.
Collaborates with internal customers to assist in developing team and individual goals through ongoing training and supplemental support.
Treats all team members as unique individuals with valuable resources and skills that enhance the team.
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, consideration of suggestions from others, participation in professional development activities, and positive input in team growth. Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback and suggestions for improvement.
Effectively participates and leads project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
Assess the complexity of situations and seeks collaborative solutions and tactful methods to diffuse highly charged situations for conflict resolution.
Effectively motivates team members by listening/implementing varying points of view, creating/supporting a climate of trust, open and honest communication, and investment in the personal growth of team members.
Effectively communicates, delegates, supervises, and prioritizes work assignments for internal and external work teams.
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.