Clin/Tran Research Coord II (Pediatric InfectiousDisease)
Discover Vanderbilt University MedicalCenter:
Locatedin Nashville, Tennessee, and operating at a global crossroads of teaching,discovery and patient care, VUMC is a community of individuals whocome to work each day with the simple aim of changing the world. It is a placewhere your expertise will be valued, your knowledge expanded and your abilitieschallenged. It is a place where your diversity â of culture, thinking, learningand leading â is sought and celebrated. It is a place where employees know theyare part of something that is bigger than themselves, take exceptional pride intheir work and never settle for what was good enough yesterday. Vanderbiltâs mission is to advancehealth and wellness through preeminent programs in patient care, education, andresearch.
MonroeCarell Jr. Children's Hospital at Vanderbilt is one of the nation's leadingchildren's hospitals. We treat and help prevent all health issues ranging fromcolds and broken bones to heart disease and cancer.
The world-class facilities atChildren's Hospital are a testament to our community's dedication to the healthof children. Constructed in 2004 and expanded in 2012, our 271-bed hospital isa child-friendly place built on the science of healing.
A building alone does not make a greathospital. Our exceptional medical teams and the generous support of people likeyou enable us to provide every child who comes to us with the hope of improvedhealth. Children's Hospital is a nonprofit facility. No child who needs ourservices is denied care on the basis of limited ability to pay.
Many of our doctors and surgeons arenationally recognized researchers who are finding new ways to cure and preventchildhood diseases. Their work preventing and treating premature birth, cancer,heart disease, spina bifida, and many other conditions is an investment in thefuture. We are at an important crossroads in child health. Our commitment toresearch and advocacy positions us to bring the promise of good health tochildren and families in our community and to share that hope with the world.
Responsiblefor coordinating the approval processes and conduct of research protocols,assuring that the integrity and quality of the research is maintained and thatthe research is conducted in accordance with Good Clinical Practice Guidelines,federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedureand research protocols. Manages screening, implements recruitment procedures,consent, enrollment, randomization and study conduct from planning throughstudy closeout. Performs or implements processes to assure study-relatedprocedures are performed as required and objectives and timelines are met.Maintains accurate and timely documentation and communication withInvestigators, participants, IRB, sponsors and other research related entities.
Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research
Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations
Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately 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, etc. Ability to identify and troubleshoot problems
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
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation
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. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
Knowledgeable of the safety reporting requirements of the study protocol, IRB, 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
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
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
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 the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
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, address or refer 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 and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, 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 10 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 submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals
Pursues professional development opportunities, including external and internal training.
Attends regional or national industry/professional meetings, conferences, and workshops.
Bachelor's Degree (orequivalent experience) and 2 years experience
VUMC Recent Accomplishments
Becausewe are committed to providing the best in patient care, education and research,we are proud of our recent accomplishments:
Â·US News & World Report: #1Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center),12 adult and 10 pediatric clinical specialties ranked among the nation's best,#15 Education and Training
Â·Truven Health Analytics: amongthe top 50 cardiovascular hospitals in the U.S.
Â·Becker's Hospital Review: oneof the "100 Greatest Hospitals in America"
Â·The Leapfrog Group: grade"A" in Hospital Safety Score
Â·National Institutes of Health: amongthe top 10 grant awardees for medical research in the US
Â·Magnet Recognition Program: Vanderbiltnurses are the only group honored in Tennessee
Â·Nashville Business Journal: MiddleTennessee's healthiest employer
Â·American Hospital Association: amongthe 100 "Most Wired" medical systems in the US
Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.