Description
Clin/Tran Research Coordinator III (Pediatric Hematology)
1909646
JOB SUMMARY: Advanced knowledge and understanding of the planning, implementation and management of research operations. Responsible for planning and management of the approval, implementation and conduct of research protocols from planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, DSMBs and other research related entities. Functions as a departmental resource in research operations. KEY RESPONSIBILITIES: Prepare and Process New Study Submissions
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Work closely with PI and/or sub-investigators to prioritize tasks for new study submissions and to identify issues and/or questions that require resolution prior to submission
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Interface with other departments at Vanderbilt and/or outside collaborative institutions to resolve issues and/or questions prior to submission
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Assist in creating research protocol, as necessary, from grant materials, information provided by PI, etc.
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Develop operational plans to implement the protocol (e.g., screening strategies, recruitment strategies, tracking mechanisms, etc.)
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Create and/or compile study forms and materials
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Create consent and assent documents
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Prepare and submit IRB application in DiscoverE
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Prepare and submit SRC application in StarBrite
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Prepare and submit eSMART billing plan and application if the protocol includes billable study procedures
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Monitor progress of above submissions, proactively resolving issues as necessary to ensure a timely review and approval of application.
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Process approval of study, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of approvals and next steps
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Update OnCore with approval information, upload appropriate documents, and open the study to accrual in OnCore
Prepare and Process Amendments to Approved Studies
Meet with PI and/or sub-investigators to identify required changes to the protocol and resolve issues prior to submission
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Revise study documents as required by the proposed changes
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Revise study procedures as required by proposed changes
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Prepare and submit the amendment IRB application in DiscoverE
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Monitor progress of amendment submission, proactively resolving issues as necessary to ensure a timely review and approval of amendment
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Process approval of the amendment, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of same and next steps
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Re-consent current participants if required by the approved changes
Prepare and Process Annual Continuing Reviews
- Maintain tracking mechanism to ensure Continuing Reviews are submitted in a timely fashion
- Work with PI and/or sub-investigators to ensure accrual information is current
- Ensure all KSP are current on CITI training, sending reminders to KSP as necessary
- Create and maintain research files for enrolled participants as per protocol
- Create and maintain Regulatory Binder for each study
- Create and maintain electronic research files for study records, materials, documentation, tracking mechanisms and participant data
Prepare and/or Obtain Study Supplies and Equipment
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Prepare survey packets, study forms, consent documents, etc. as required by protocol
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Order study supplies from sponsors as required
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Purchase postage and gift cards as required
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Purchase or obtain study equipment as required
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Monitor inventory of the above to ensure supplies are always adequate for implementation of the study procedures in a timely fashion
Work Cooperatively with Auditors, both Internal and External, to Complete Study Reviews
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Review study procedures and documentation to ensure an accurate research record prior to an audit or site visit
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Make arrangements for auditor work space and access to required documentation
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Assist auditor as necessary
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Respond to auditor's results document (CAP, etc.) as required
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Revise and/or correct documentation and study procedures as identified in the audit as required
Train and Mentor New Staff and Student Interns
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Assist in onboarding new staff by providing necessary training, answering questions, and mentoring as necessary
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Create opportunities for student interns to learn about research while contributing to the research efforts of our division
Position Qualifications:
Required:
* Bachelors Diploma (or equivalent experience) and 5 years of experience.
Position Shift:
* Day Shift/ Exempt Position
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 ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
* Truven Health Analytics: among the top 100 hospitals in the US
* 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
* American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
* 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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