Position provides overall direction for training and quality assurance to ensure VICC Clinical Trials Office (CTO) staff is trained to conduct clinical research in accordance with FDA guidelines, Good Clinical Practice, institutional review board, and VICC requirements. Oversees ongoing quality assurance through monitoring, quality data checks, and process improvements. Coordinates onboarding of all new staff and ongoing training to ensure role specific research competencies. Works closely with Clinical Trials Office Director and Medical Director to maintain highest standards of research compliance.
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/
View how Vanderbilt Health employees celebrate the difference they make every day:
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.
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:
Leading: Managing Vision and Purpose, Motivating and Influencing
Works with medical and administrative staff to operationalize the mission, strategic plan, resource allocation, operational plans, and policies for the VICC Clinical Trials Shared Resource. Collaborates with central nursing education department on enterprise wide initiatives.
Manages multiple projects/ work activities (timelines, work plans, deliverables) and maintains alignment with strategic plan and vision.
Partners with the leadership team, determines areas for improvement in clinical research practice and develops improvement plans
Collaborates across organization to identify and develop innovative strategies that increase efficiency, decrease expense, and integrate clinical and research care.
Recognizes and rewards desired performance, mentors others in the use of the continuous improvement process, shares results with others through verbal and written communication. Supports retention of staff through the use of techniques consistent with Elevate framework.
Communication: Active Listening and Communicating Clearly (verbal and written)
Embodies VUMC credo. Develops an environment of trust, fairness, consistency and confidentiality with diverse team members and with other internal and external customers.
Listens and seeks clarification using Elevate principles. Uses findings to develop evidence based solutions to identified clinical and/or educational issues within scope of accountability.
Shares knowledge and collaborates across disciplines and PCC. Communicates effectively orally and in writing. Advocates for staff education/development needs to the leadership team.
Quality Assurance: Develop, implement, and monitor quality assurance SOPs and standards.
Develop and maintain formalized quality assurance/quality control (QA/QC) policies and written SOPs for CTO staff and Biospecimen laboratory staff and operations in accordance with FDA guidelines, GCPs, IRB and VICC mission
Annually plan and implement a quality assurance plan to ensure high quality data management, regulatory compliance, and research nursing.
Identify, measure, analyze and report benchmarks that demonstrate quality research is being conducted.
Summarize and present protocol deviation data in a format that will facilitate identification and prioritization of improvement initiatives.
Review all SAEs for trends of concern and to ensure timely and accurate reporting to all study sponsors.
Coordinates data and process analysis needs with CTO director, managers, medical director, and steering committee resulting in informed decision making.
Training: Onboarding and Ongoing Training of all Staff
Assists management team in planning and implementing orientation programs for new staff members on research processes; incorporating relevant policy into the orientation processes; developing systems/processes to help staff meet competency requirements; ensuring staff is competent in the process of subject recruitment, study enrollment, and follow-up for subjects that participate in research oncology trials; utilizing available technology (including simulation) and other creative instructional strategies in orientation and ongoing education.
Plans, implements, evaluates, and revises mandatory annual training for staff in accordance with JCAHO, OSHA, OHRP, FDA, CFR and area/hospital policies. Tracks staff compliance in collaboration with leadership team.
Active participant in clinical research practice SOP development and revision including planning and implementing educational programs for new/changing technology. Takes a leadership role in determining how new/changing technology is used in the CTSR.
Identify learning needs for re-education and conduct training on these topics as needed.
Conducts learning needs assessments for individuals/groups of staff. Provides CTSR management team with staff performance data in relation to established internal and external benchmarks.
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.