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Clin/Tran Research Coordinator III (Pediatric Hematology)1909646JOB 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 Submissionsa. 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 submissionb. Interface with other departments at Vanderbilt and/or outside collaborative institutions to resolve issues and/or questions prior to submissionc. Assist in creating research protocol, as necessary, from grant materials, information provided by PI, etc.d. Develop operational plans to implement the protocol (e.g., screening strategies, recruitment strategies, tracking mechanisms, etc.)e. Create and/or compile study forms and materialsf. Create consent and assent documentsg. Prepare and submit IRB application in DiscoverEh. Prepare and submit SRC application in StarBritei. Prepare and submit eSMART billing plan and application if the protocol includes billable study proceduresj. Monitor progress of above submissions, proactively resolving issues as necessary to ensure a timely review and approval of application.k. Process approval of study, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of approvals and next stepsl. Update OnCore with approval information, upload appropriate documents, and open the study to accrual in OnCorePrepare and Process Amendments to Approved StudiesMeet with PI and/or sub-investigators to identify required changes to the protocol and resolve issues prior to submissiona. Revise study documents as required by the proposed changesb. Revise study procedures as required by proposed changesc. Prepare and submit the amendment IRB application in DiscoverEd. Monitor progress of amendment submission, proactively resolving issues as necessary to ensure a timely review and approval of amendmente. Process approval of the amendment, notifying appropriate Vanderbilt departments and/or collaborative outside institutions of same and next stepsf. Re-consent current participants if required by the approved changesPrepare 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 Equipmenta. Prepare survey packets, study forms, consent documents, etc. as required by protocolb. Order study supplies from sponsors as requiredc. Purchase postage and gift cards as requiredd. Purchase or obtain study equipment as requirede. Monitor inventory of the above to ensure supplies are always adequate for implementation of the study procedures in a timely fashionWork Cooperatively with Auditors, both Internal and External, to Complete Study Reviewsa. Review study procedures and documentation to ensure an accurate research record prior to an audit or site visitb. Make arrangements for auditor work space and access to required documentationc. Assist auditor as necessaryd. Respond to auditor’s results document (CAP, etc.) as requirede. Revise and/or correct documentation and study procedures as identified in the audit as requiredTrain and Mentor New Staff and Student Internsa. Assist in onboarding new staff by providing necessary training, answering questions, and mentoring as necessaryb. Create opportunities for student interns to learn about research while contributing to the research efforts of our divisionPosition Qualifications:Required:· Bachelors Diploma (or equivalent experience) and 5 years of experience.Position Shift:· Day Shift/ Exempt PositionDiscover 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 DiscoveryVUMC Recent AccomplishmentsBecause 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 http://www.vanderbilthealth.com/billwilkerson/ ), 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 USCAAdditional Qualification Information:
Prior to advancing to a Clinical/Translational Research Coordinator III must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.
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.
Environmental ConditionsJob ResearchOrganization: Pediatric Hematology 104598Title: Clin/Tran Research Coord III, Pediatric HematologyLocation: TN-Nashville-Preston Cancer Research BuildingRequisition ID: 1909646Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.
