Clinical Trials Operations Manager
Vanderbilt University Medical Center
Clinical Trial OperationsManager
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mission is to advance health and wellness through preeminent programs in patient care, education, and research.
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VICTR is Vanderbiltâ€™s
virtual home for clinical and translational research. Supported by **MEMBERS ONLY**SIGN UP NOW***.
Medical Centerâ€™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.
Throughout the conceptualphase of the project, assists (as applicable) with protocol developmentfrom a scientific, statistical, regulatory, and administrativeperspective.
Assists in identifying,evaluating, and selecting national/global sites for Clinical Trialparticipation.
Works with theNational/International Principal Investigator in order to identifyClinical Trial key collaborators and resources and assists thesecollaborators throughout the lifespan of the Clinical Trial. These collaborators may include anindependent Core Lab, Medical Safety Monitor(s), Biostatistician(s),Independent Randomization Reviewer(s), Radiologist(s), and any otherapplicable resources required by the Clinical Trial.
With oversight from the Officeof Contracts Management, facilitates the subcontracting process betweenVanderbilt University and participating Clinical Trial sites.
Â· 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.
Â· 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 clinicaltrial workflow, provide accountability, set milestones, and identifyexpectations in order to ensure the trialâ€™s overall success.
Â· Troubleshoots recruitment problems, reporting
problems and works with research coordinators and investigators at
participating institutions to ensure compliance with project standards.
Â· 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
Â· 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
Actively demonstratesfacilitative leadership to foster productive teamwork amongst ClinicalTrial Site Investigators and their study staff, Clinical Trialcollaborators, the Clinical Trial sponsor(s) and/or financial partners,applicable Clinical Trial committees, and the internal Clinical Trialteam at Vanderbilt University Medical Center (which may includecollaborators in Biostatistics, The Department of Medicine, the Sectionof Surgical Sciences, BioMedical Informatics, Office of ContractsManagement, Office of Sponsored Programs, Finance, the Human Research ProtectionProgram, etc.).
Â· Uses the projectâ€™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.) forparticipating Clinical Trial sites.May require travel to participating sites to conduct initialand/or ongoing training.
With oversight, serves as aresource for developing the initial Clinical Trial Agreement/Contractbetween Vanderbilt University and the Clinical Trial sponsor(s).
Â· 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 regulatoryreview for participating Clinical Trial sites in order to maintaincompliance with applicable local, state, and federal laws and bestpractices.
Oversees safety profile ofthe Clinical Trial by reviewing Serious Adverse Event reports, ProtocolDeviations, and other unanticipated events that occur at Clinical Trialsites and ensures that events are reported to proper authorities in atimely manner.
Oversees continuedinstitutional approval and applicable amendments at participatingClinical Trial sites that involve Institutional Review Boards and/oroutside Contracts and Grants Offices.
Responsible for developing,amending, and maintaining electronic data-capture systems associatedwith all aspects of multicenter data collection and study workflow.
Â· 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 automatictriggers into electronic data-capture systems in order to highlightissues in current datasets and generates queries when questions ariseregarding data accuracy for each participating Clinical Trial site.
Communicates with theNational/Global Principal Investigator, Site Investigators, and/orClinical Trial committee members as needed regarding the status ofClinical Trial data by running frequent reports in order to identifygaps. Develops and implementscorrective action plans in order to encourage accurate and completedatasets.
Oversees the verificationprocess for the electronic data submitted from national/global ClinicalTrial sites which may also include the oversight of Clinical ResearchData Specialists who directly interact with the trialâ€™s data. Responsible for the oversight of theprojectâ€™s monitoring process where study data is compared to originalsource documentation in order to ensure data accuracy while incorporatingapplicable laws and guidance.Travels to Clinical Trial sites as necessary in order to verifydata accuracy.
Develops and incorporatescentralized and local (i.e.,: on-site) data monitoring plans and methodsin order to ensure that final trial data is accurate and complete beforeanalysis and publication occur.
Responsible for identifying,assigning, monitoring, and maintaining appropriate levels of internaland external user access to Clinical Trial related data and studymaterials.
Â· Develops standard processes for participating
institutions surrounding the status of the projectâ€™s current dataset,
compliance records, safety profile, and fiscal activities.
Â· 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 attendscommittee meetings, collaborator meetings, and internal operationalmeetings related to the Clinical Trial (which may require travel).
Â· 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.
Â· Compiles data on trial activities, quality of
reporting based on contractual terms, and compares this information when
processing invoices from individual sites.
Â· Works directly with the Principal Investigator,
sponsors, and federal government to identify additional funding opportunities
May assist in writinggrant proposals based upon established guidelines.
Tracks and monitorsexpenditures against budget.
Assists with progressreport submissions to funding source and/or Program Director.
Bachelor's Degree (Master's Preferred)
2 years of relevant experience
VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
Â· US News & World Report:
#1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center at ~~~/ ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
Â· Truven Health Analytics:
among the top 50 cardiovascular hospitals in the U.S.
Â· Becker's Hospital Review:
one of the 100 Greatest Hospitals in America
Â· The Leapfrog Group:
grade A in Hospital Safety Score
Â· National Institutes of Health:
among the top 10 grant awardees for medical research in the US
Â· Magnet Recognition Program:
Vanderbilt nurses are the only group honored in Middle Tennessee
Â· Nashville Business Journal:
Middle Tennessee's healthiest employer
Â· American Hospital Association:
among the 100 Most Wired medical systems in the US
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Physical Requirements/Strengths needed & Physical Demands:
Occasional: Sitting: Remaining in seated position
Occasional: Standing: Remaining on one's feet without moving.
Occasional: Walking: Moving about on foot.
Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
Occasional: Push/Pull: Exerting force to move objects away from or toward.
Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
Clinical Trials Operations Manager
TN-Nashville-2525 West End Ave