PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Clin/Tran Research Coordinator III (Pediatric Hematology)
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.
Prepare and Process New Study Submissions
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
Interface with other departments at Vanderbilt and/or outside collaborative institutions to resolve issues and/or questions prior to submission
Assist in creating research protocol, as necessary, from grant materials, information provided by PI, etc.
Develop operational plans to implement the protocol (e.g., screening strategies, recruitment strategies, tracking mechanisms, etc.)
Create and/or compile study forms and materials
Create consent and assent documents
Prepare and submit IRB application in DiscoverE
Prepare and submit SRC application in StarBrite
Prepare and submit eSMART billing plan and application if the protocol includes billable study procedures
Monitor progress of above submissions, proactively resolving issues as necessary to ensure a timely review and approval of application.
Process approval of study, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of approvals and next steps
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
Revise study documents as required by the proposed changes
Revise study procedures as required by proposed changes
Prepare and submit the amendment IRB application in DiscoverE
Monitor progress of amendment submission, proactively resolving issues as necessary to ensure a timely review and approval of amendment
Process approval of the amendment, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of same and next steps
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
Prepare survey packets, study forms, consent documents, etc. as required by protocol
Order study supplies from sponsors as required
Purchase postage and gift cards as required
Purchase or obtain study equipment as required
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
Review study procedures and documentation to ensure an accurate research record prior to an audit or site visit
Make arrangements for auditor work space and access to required documentation
Assist auditor as necessary
Respond to auditor's results document (CAP, etc.) as required
Revise and/or correct documentation and study procedures as identified in the audit as required
Train and Mentor New Staff and Student Interns
Assist in onboarding new staff by providing necessary training, answering questions, and mentoring as necessary
Create opportunities for student interns to learn about research while contributing to the research efforts of our division
* Bachelors Diploma (or equivalent experience) and 5 years of experience.
* 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.
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
Internal Number: 1909646
About Vanderbilt Health
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.