Posted Title: Sr. Clinical Trial Operations Manager
VICTR – Vanderbilt Coordinating Center – VCC
Requisition Number 190043
Your Role :
In your pivotal role as a Clinical Trial Operations Manager, you will serve to lead 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 provide supervision of multiple Clinical Research Data Specialists that ensure data accuracy across participating clinical research sites. You will direct 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 takes the lead 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.
· Oversees the electronic data-capture 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.
Bachelor's Degree (or equivalent experience) and 5 years experience
About the Department :
The mission of the Vanderbilt Institute for Clinical and Translational Research (VICTR) , which is of strategic importance to our institution and its research operation, is to remove impediments to translational science so that innovations reach the people who need them more quickly. We are a workforce united not only by common purpose but also by common values.
In collaboration with the VUMC Human Research Protections Program (HRPP), the Translational Research Navigator II assists with the optimal application of the Federal, State, and local laws, guidance documents, VUMC Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VUMC research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The TRN II researches topics of departmental, institutional or strategic importance.
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.
Click Here To View The VUMC Promise of Discovery
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