Clin/Tran Research Coord III, Pediatric Hematology

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.Department Summary:Children's Hospital's Hematology Program offers compassionate, comprehensive, family-centered care for children and young adults with blood cell disorders, bleeding disorders and clotting disorders. We provide education and counseling, and connect you with advocacy programs here in Nashville and across the nation. We'll also let you know if your child may be eligible to participation in a Vanderbilt clinical trial or research.Why Choose Care at Children's Hospital for Pediatric HematologyVanderbilt offers a nationally recognized, federally funded Hemophilia Treatment Center (HTC). Our clinic is part of a network of about 140 HTCs in the United States. National studies show that children treated at HTCs spend less time in the hospital, less time away from school, and have better outcomes and lower healthcare costs.The Vanderbilt-Meharry-Matthew Walker Center of Excellence in Sickle Cell Disease at https://www.childrenshospitalvanderbilt.org/program/sickle-cell-center-excellence is a nationally recognized program that brings together primary care providers and specialists from local institutions to treat individuals with sickle cell disease under one roof.We are part of the only multidisciplinary Vascular Malformation Team at https://www.childrenshospitalvanderbilt.org/program/hemangiomas-and-vascular-malformations in middle Tennessee. This team consists of providers from Pediatric Hematology, Otolaryngology at https://www.childrenshospitalvanderbilt.org/service-line/pediatric-otolaryngology-head-neck-surgery , Dermatology at https://www.childrenshospitalvanderbilt.org/service-line/dermatology , Cardiology at https://www.childrenshospitalvanderbilt.org/service-line/pediatric-heart-institute , Surgery at https://www.childrenshospitalvanderbilt.org/service/general-thoracic-surgery , Genetics at https://www.childrenshospitalvanderbilt.org/service-line/genetics-and-genomic-medicine , Interventional Radiology, and Diagnostic Radiology at https://www.childrenshospitalvanderbilt.org/service-line/diagnostic-imaging .We offer a comprehensive program for care of children with bleeding, clotting at https://www.childrenshospitalvanderbilt.org/program/hemophilia-and-blood-disorders , or blood cell disorders at https://www.childrenshospitalvanderbilt.org/program/hemostasis-treatment-center within our clinic as well as throughout the hospital. Our team consists of physicians, clinical nurses, case managers, social workers, child life specialists, and pharmacists. All team members work to provide complete care and education for you and your children as you navigate hematologic concerns.Our medical professionals and family support team members have experience and special interest in caring for children and young adults with blood disorders. We work closely with your family to determine the best treatment options and approach.Position Shift:· Day Shift/ Non-Exempt PositionClick here to view how Vanderbilt Health employees celebrate the difference they make every day:Celebrate 2019Click Here To View The VUMC Promise of DiscoveryDiscover 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.VUMC 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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children’s Hospital at Vanderbilt named as one of the Best Children’s Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.· Healthcare’s Most Wired: Among the nation’s 100 “most-wired” hospitals and health systems for its efforts in innovative medical technology.· Becker’s Hospital Review: named as one of the “100 Great Hospitals in America”, in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.· The Leapfrog Group: One of only 10 children’s hospitals in the to be named at Leapfrog Top Hospital.· American Association for the Advancement of Science: The School of Medicine has 112 elected fellows· Magnet Recognition Program: Received our third consecutive Magnet designations.· National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement· Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.Additional Key Elements/ Responsibilities:KEY RESPONSIBILITIES:Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, budgets, and D&H accounts

Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations

Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process

Advanced knowledge and understanding of the management and implementation of clinical/translational research operations

Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures. Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. Problem solves when needed

Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews

Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)

Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner

Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools

Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes

Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation

Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation

With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies

With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies

Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures

Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants

With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation

Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial

Engages in open communication with participants by providing them with contact information and being available to answer their calls

Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies

Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations

Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc.)

Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work

Engages in a minimum of 15 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification

Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor

Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing CTRSC meeting Council information summaries, attending meetings open to research staff and by sharing information with other research personnel

Actively seeks new learning opportunities, seeing continued learning as part of work. Develops and achieves personal and professional goals

Serves as a role model, mentor and consultant

Participates in groups within the institution to contribute to the improvement and development of the research environment

Participates at local professional meetings

Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting

Supports process improvement in clinical/translational research management to speed up study activation, implementation, conduct, close out, and reporting

Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes

Networks with other research departments and colleagues to share best practices

Develops recruitment and retention strategies to improve study performance

Continually revises operating procedures to assure quality and human subjects protection

Position Qualifications:·Bachelor's Degree (or equivalent experience) and 5 years experienceCAIND000NHCNAdditional 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:MovementOccasional: 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.

SensoryOccasional: 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: 2009963Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.