Clinical Trials Manager - VICTR - Vanderbilt Coordinating Center (VCC)
This is a full-time/exempt term position lasting six months to one year.
In your pivotal role as a Clinical Trials Manager, you will be supporting 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. Ensure data accuracy across participating clinical research sites. You will direct long-range strategic planning for each clinical trial, including setting goals and objectives. Ensure that goals and milestones remain on track and develop and implements corrective action plans 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 .
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Manages and operationally delivers clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out.
Ensures appropriate communication and ongoing leadership of assigned trial(s) by working in close collaboration with the sponsor and other functional team members.
Identifies challenges to study timelines/deliverables and offers creative action plans to the team/sponsor.
Maintains team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
STUDY DESIGN & DEVELOPMENT (INTERMEDIATE)
Throughout the conceptual phase of the project, assist (as applicable) with protocol development from a scientific, statistical, regulatory, and administrative perspective. Assist in identifying, evaluating, and selecting national/global sites for Clinical Trial participation. Work with Principal Investigator 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, facilitate the subcontracting process between VUMC and participating Clinical Trial sites. Work with the Principal Investigator to develop appropriate Clinical Trial committees and assist 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.
CLINICAL TRIAL IMPLEMENTATION (INTERMEDIATE)
Within the regulations of the FDA and other governing bodies, implement processes for proper trial coordination at participating centers and individualize processes when necessary to ensure protocol compliance by accommodating unique workflows. Develop written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters to streamline clinical trial workflow, provide accountability, set milestones, and identify expectations to ensure the trial's overall success. With oversight, serve as a resource for developing the initial Clinical Trial Agreement/Contract between VUMC and the Clinical Trial sponsor(s). Work directly with 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. Use the project's protocol to determine the content of the training materials, databases, data collection documents, monitoring plans, and other details that are trial specific. Create, distribute, and update (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. Become familiar with current trends in technology, market pressures and resources, and leverage relationships with key stakeholders within the research community facilitate the project's success.
TRIAL MANAGEMENT (INTERMEDIATE)
Perform ongoing regulatory review for participating Clinical Trial sites to maintain compliance with applicable local, state, and federal laws and best practices. Maintain 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 ensure that events are reported to proper authorities in a timely manner. Oversee continued institutional approval and applicable amendments at participating Clinical Trial sites that involve Institutional Review Boards and/or outside Contracts and Grants Offices. Develop, amend, and maintaining electronic datacapture systems associated with all aspects of multicenter data collection and study workflow. Assist with electronic datacapture 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. Organize and/or attend committee meetings, collaborator meetings, and internal operational meetings related to the Clinical Trial (which may require travel). Troubleshoot recruitment problems, reporting problems and work with research coordinators and investigators at participating institutions to ensure compliance with project standards. Ensure that participating Clinical Trial sites remain compliant with data submission and other applicable reporting criteria before payments are issued according to their individual subcontracts. Compile data on trial activities and quality of reporting based on contractual terms, and compare this information when processing invoices from individual sites. Track and monitor expenditures against budget. Assist with progress report submissions to funding source and/or Program Director.
DATA MANAGEMENT (INTERMEDIATE)
Incorporate automatic triggers into electronic datacapture systems to highlight issues in current datasets and generate queries when questions arise regarding data accuracy for each participating Clinical Trial site. Communicate with the Principal Investigator, Site Investigators, and/or Clinical Trial committee members as needed regarding the status of Clinical Trial data by running frequent reports in identify gaps. Develop and implement corrective action plans to encourage accurate and complete datasets. Oversee the verification process for the electronic data submitted from national/global Clinical Trial sites, which may also include the oversight of Clinical Research Associates who directly interact with the trial's data. Oversee the project's monitoring process where study data is compared to original source documentation to ensure data accuracy while incorporating applicable laws and guidance. Travel to Clinical Trial sites as necessary to verify data accuracy. Develop and incorporate centralized and local (i.e., onsite) data monitoring plans and methods to ensure that final trial data is accurate and complete before analysis and publication occur. Identify, assign, monitor, and maintain appropriate levels of internal and external user access to Clinical Trial related data and study materials. Develop standard processes for participating institutions surrounding the status of the project's current dataset, compliance records, safety profile, and fiscal activities. Compile data, reports, and outcome to develop reports and presentations for various trial committees and sponsors that are reflective of current and future financial, safety, compliance, and enrollment milestones.
PROJECT LEADERSHIP (INTERMEDIATE)
Responsible for establishing consistent methods for study communication keep project on track, foster collaboration, improve communication, and continually gather support from participating institutions. Actively demonstrate facilitative leadership to foster productive teamwork among Clinical Trial Site Investigators and their study staff, Clinical Trial collaborators, the Clinical Trial sponsor(s) and/or financial partners, applicable Clinical Trial committees, and the internal Clinical Trial team at Vanderbilt University Medical Center (which may include collaborators in Biostatistics, The Department of Medicine, the Section of Surgical Sciences, biomedical Informatics, Office of Contracts Management, Office of Sponsored Programs, Finance, the Human Research Protection Program, etc.). Leads CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities.
This is a term position. A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. This position may also have the opportunity to work remotely.
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.