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.
Throughout the conceptual phase of the project, oversee (as applicable) with protocol development from a scientific, statistical, regulatory, and administrative perspective.
Identifies, evaluates, and selects 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 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.
Develops 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.
· 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.
Actively demonstrates facilitative leadership to foster productive teamwork amongst 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.).
· 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.
Creates, 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.
Serves as a resource for developing the initial Clinical Trial Agreement/Contract between Vanderbilt University and the Clinical Trial sponsor(s).
· 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.
Performs ongoing regulatory review for participating Clinical Trial sites in order to maintain compliance with applicable local, state, and federal laws and best practices.
Oversees 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.
Oversees continued institutional approval and applicable amendments at participating Clinical Trial sites that involve Institutional Review Boards and/or outside Contracts and Grants Offices.
Responsible for developing, amending, and maintaining electronic data-capture systems associated with all aspects of multicenter data collection and study workflow.
· 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.
Oversees the incorporation of 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. Develops and implements corrective action plans in order to encourage accurate and complete datasets.
Oversees the verification process for the electronic data submitted from national/global Clinical Trial sites which may also include the oversight of Clinical Research Data Specialists who directly interact with the trial's data. Responsible for the oversight of 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.
Develops and incorporates 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.
· 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 .
Organizes and/or attends committee meetings, collaborator meetings, and internal operational meetings related to the Clinical Trial (which may require travel).
· 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.
May assist in writing grant proposals based upon established guidelines.
Tracks and monitors expenditures against budget.
Oversees progress report submissions to funding source and/or Program Director.
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.
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
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 th...e 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.