Responsible for clinical trial operations within the Vanderbilt-Ingram Cancer Center (VICC) Clinical Trials Office (CTO). The Assistant Director of Research Operations will report to the VICC Director for Clinical Research Administration and collaborate with the Assistant Director of Trial Management, the Assistant Director of Clinical Operations, the Chief of Clinical Trials, and the CTO Medical Director to ensure the successful conduct of clinical trials across VICC. The Assistant Director of Research Operations will oversee the CTO Data Team, the CTO Regulatory Team, the VICC Coordinating Center, the Scientific Review Committee administrative staff, and other areas as assigned. This position will provide oversight for an increasingly large and complex clinical trials operation at the VICC to ensure streamlined data collection and reporting and optimal regulatory processes in fulfilling the clinical research mission of VICC.
Current areas of responsibility include data integrity, regulatory management, protocol development and monitoring, resource allocation across disease teams, and process improvement for data and regulatory functions. This position will:
Utilize leadership skills to provide oversight and management to ensure safe, compliant, efficient, and effective conduct of the clinical trials within the VICC portfolio.
Hire staff and have responsibility for delegating tasks, monitoring workloads, and evaluating job performance.
Establish, implement, and evolve operational standards and monitor quality and progress of process improvement and program growth.
Foster employee engagement and retention via creation of career ladders, continuing education and professional development, and recognition of high performing individuals.
Interface with other VUMC departments, leaders across the organization and other partners in the administration of the program to identify and define any logistics, action items or information needed to maintain operations.
Ensure compliance with regulatory requirements and institutional policies for clinical trial conduct at VICC while acting as the VICC CTO liaison to the Office of Human Subjects Research Protection.
Oversee institutional review board (IRB) document preparation and submission by both the Regulatory Team and Coordinating Center staff.
Oversee Investigator Initiated protocol applications from LOI creation to study completion.
Oversee study staff communication with the sponsor, IRB, Data and Safety Monitoring Committee (DSMC), regulatory agencies and other research related entities.
Review monitoring reports recommend appropriate actions and when necessary assist in implementing solutions.
Identify and escalate support needs for high profile/high audit risk clinical trials.
Work collaboratively with the CTO Data Team and Assistant Director of Clinical Operations to make sure data is collected, managed, and reported clearly, accurately, and securely to Disease Team Leaders and Sponsors.
Work collaboratively with CTO leadership to identify and optimize systems platforms in support of regulatory and data operations.
Ensure completeness, correctness and consistency of routine clinical data and data structure, and implement routine reporting mechanisms to track study progress and ensures timeliness and quality expectations are met.
Oversee the administrative support team for the Scientific Review Committee and ensure that processes and documentation align with National Cancer Institute (NCI) Cancer Center Support Grant guidelines.
Research, gather, organize, and summarize data for evaluating performance of program or other program operations.
Develop, evaluate, recommend, and implement procedures for performance improvement and quality control.
Ensure accountability in clinical research practices, ALCOAC principles, and ICH-GCP.
Review SOPs/guidelines, audit reports, incident reports, while initiating corrective and preventive action to ensure best practice.
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/
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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: 6 th 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.