Clinical Trial Operations Manager
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VICTR is Vanderbilt's virtual home for clinical and translational research. Supported by the Vanderbilt University Medical Center's Office of Research and the NIH sponsored Clinical and Translational Science Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. This is accomplished using a multi-faceted approach: through collaboration with a wide variety of research partners; by training, nurturing and rewarding participating researchers; by funding research; by developing new and innovative ways to involve the community in research; by developing new informatics and biostatistical systems; and by making available the latest technologies and sound research results affecting patient care.
Serves 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. May provide supervision of multiple Clinical Research Data Specialists that ensure data accuracy across participating clinical research sites. Directs long-range strategic planning for the clinical trial, including the setting of goals and objectives. Ensures that goals and milestones remain on track and develops and implements corrective action plans in an effort to improve performance when needed.
· 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, implements processes for proper trial coordination at participating centers and individualizes processes when necessary in order to ensure protocol compliance by accommodating unique workflows.
· 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.
· Responsible for 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 determine the content of the training materials, databases, data collection documents, monitoring plans, and other details that are trial specific.
· Works 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.
· 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.
· Develops 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 in order to develop reports and presentations for various trial committees and sponsors that are reflective of current and future financial, safety, compliance, and enrollment milestones.
· 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 identify additional funding opportunities when needed.
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 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
· Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
· Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
· The Leapfrog Group: grade "A" in Hospital Safety Score
· National Institutes of Health: among the top 10 grant awardees for medical research in the US
· Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
· Nashville Business Journal: Middle Tennessee's healthiest employer
· American Hospital Association: among the 100 "Most Wired" medical systems in the US
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