In your pivotal role as an Assoc. Clinical Trials Manager you will serve to support the design and conduct of operational activities related to planning, implementing, executing, and reporting of multicenter clinical trials in accordance with standard operating procedures, Good Clinical Practice, and local and federal regulations. You will help to ensure data accuracy across participating clinical research sites. You will also assist in directing long-range strategic planning for the clinical trial, including the setting of goals and objectives. Help to ensure that goals and milestones remain on track and develops and implements corrective action plans in an effort to improve performance when needed.
About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Throughout the conceptual phase of the project, assists (as applicable) with protocol development from a scientific, statistical, regulatory, and administrative perspective.
Assists in identifying, evaluating, and selecting national/global sites for Clinical Trial participation.
Works with the National/International Principal Investigator in order to identify Clinical Trial key collaborators and resources and assists these collaborators throughout the lifespan of the Clinical Trial. These collaborators may include an independent Core Lab, Medical Safety Monitor(s), Biostatistician(s), Independent Randomization Reviewer(s), Radiologist(s), and any other applicable resources required by the Clinical Trial.
With oversight from the Office of Contracts Management, facilitates the subcontracting process between Vanderbilt University and participating Clinical Trial sites.
Works with the National/International Principle Investigator to develop appropriate Clinical Trial committees and assists in meeting the ongoing needs of assigned committees. These committees may include a Data, Safety, and Monitoring Board; Steering Committee; Clinical Improvement Committee; and Trial Operational Committee.
Within the regulations of the FDA and other governing bodies, assists in implementing processes for proper trial coordination at participating centers and individualizing processes when necessary in order to ensure protocol compliance by accommodating unique workflows.
Assists in developing written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters in order to streamline clinical trial workflow, provide accountability, set milestones, and identify expectations in order to ensure the trial's overall success.
Troubleshoots recruitment problems, reporting problems and works with research coordinators and investigators at participating institutions to ensure compliance with project standards.
Familiarizes themselves with current trends in technology, market pressures, resources, and leverages relationships with key stakeholders within the research community in order to facilitate the project's success.
Assists in establishing consistent methods for study communication in an effort to keep project on track, foster collaboration, improve communication, and continually gather support from participating institutions.
Uses the project's protocol to suggest the content of the training materials, databases, data collection documents, monitoring plans, and other details that are trial specific.
Distributes and updates (as necessary) all Clinical Trial training materials (i.e.,: videos, questionnaires, presentations, newsletters, etc.) for participating Clinical Trial sites. May require travel to participating sites to conduct initial and/or ongoing training.
With oversight, serves as a resource for developing the initial Clinical Trial Agreement/Contract between Vanderbilt University and the Clinical Trial sponsor(s).
Works directly with supervisor, the Office of Sponsored Programs, Office of Contracts Management and with the appropriate contacts at outside institutions to ensure all applicable regulations are met during the initiation of the project.
With oversight, performs ongoing regulatory review for participating Clinical Trial sites in order to maintain compliance with applicable local, state, and federal laws and best practices.
With oversight, reviews safety profile of the Clinical Trial by reviewing Serious Adverse Event reports, Protocol Deviations, and other unanticipated events that occur at Clinical Trial sites and ensures that events are reported to proper authorities in a timely manner.
Assists with continued institutional approval and applicable amendments at participating Clinical Trial sites that involve Institutional Review Boards and/or outside Contracts and Grants Offices.
Helps in developing, amending, and maintaining electronic data-capture systems associated with all aspects of multicenter data collection and study workflow.
Assists with electronic data-capture support and may oversee a project specific hotline where participants can receive assistance with regulatory needs, system support, clinical questions and/or receive enrollment support.
Incorporates automatic triggers into electronic data-capture systems in order to highlight issues in current datasets and generates queries when questions arise regarding data accuracy for each participating Clinical Trial site.
Communicates with the National/Global Principal Investigator, Site Investigators, and/or Clinical Trial committee members as needed regarding the status of Clinical Trial data by running frequent reports in order to identify gaps. Assists in developing and implementing corrective action plans in order to encourage accurate and complete datasets.
Assists in the verification process for the electronic data submitted from national/global Clinical Trial sites. With oversight, reviews the project's monitoring process where study data is compared to original source documentation in order to ensure data accuracy while incorporating applicable laws and guidance. Travels to Clinical Trial sites as necessary in order to verify data accuracy.
Works to develop and incorporate centralized and local (i.e.,: on-site) data monitoring plans and methods in order to ensure that final trial data is accurate and complete before analysis and publication occur.
Responsible for identifying, assigning, monitoring, and maintaining appropriate levels of internal and external user access to Clinical Trial related data and study materials.
Assists in developing standard processes for participating institutions surrounding the status of the project's current dataset, compliance records, safety profile, and fiscal activities.
Compiles data, reports, and outcome measures for reports and presentations for various trial committees and sponsors that are reflective of current and future financial, safety, compliance, and enrollment milestones.
Organizes and/or attends committee meetings, collaborator meetings, and internal operational meetings related to the Clinical Trial (which may require travel).
With supervision, ensures that participating Clinical Trial sites remain compliant with data submission and other applicable reporting criteria before payments are issued according to their individual subcontracts.
Compiles data on trial activities, quality of reporting based on contractual terms, and compares this information when processing invoices from individual sites.
Works directly with the Principal Investigator, sponsors, and federal government to help identify additional funding opportunities when needed.
May assist in writing grant proposals based upon established guidelines.
Tracks and monitors expenditures against budget.
Assists with progress report submissions to funding source and/or Program Director.
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.