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Clinical Trials Operations Manager

Company name
The Vanderbilt University

Location
Nashville, TN

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Clinical Trials Operations Manager

Vanderbilt University Medical Center

Nashville

TN

Job #685449423

Clinical Trial OperationsManager

Requisition 1801896

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

Department/Unit Summary:

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.

Job Summary:

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.

Key Functions:

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.

· 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.

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 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 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.).

· 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.) 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).

· 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.

· 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 trial’s data. Responsible for the oversight of theproject’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.

· 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 attendscommittee meetings, collaborator meetings, and internal operationalmeetings 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 writinggrant proposals based upon established guidelines.

Tracks and monitorsexpenditures against budget.

Assists with progressreport submissions to funding source and/or Program Director.

REQUIRED

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:

· 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

· 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

Download the Vanderbilt University Medical Center Facts 2016-2017 at ~~~ to learn more about our services and facilities.

*CA

Physical Requirements/Strengths needed & Physical Demands:

Movement

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.

Sensory

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.

Job

Research

Organization:

VICTR 104242

Title:

Clinical Trials Operations Manager

Location:

TN-Nashville-2525 West End Ave

Requisition ID:

1801896

Updated 06/13/2018

Company info

The Vanderbilt University
Website : http://www.vanderbilt.edu

Company Profile
Over the years, we have discovered that you can’t contain a neuroscientist’s love of dance any more than a mechanical engineer’s fascination with pre-Columbian tribes. We have long encouraged students to study across disciplines, then bring them together to address problems from new perspectives. It’s a school of thought that favors collaboration over competition in true Vanderbilt tradition.

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