Clin/Tran Research Coord I (Pediatric Endocrinology)
Discover Vanderbilt University Medical Center:
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 agreat hospital. Our exceptional medical teams and the generous support ofpeople like you enable us to provide every child who comes to us with the hopeof improved health. Children's Hospital is a nonprofit facility. No child whoneeds our services 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.
Conveys a basic knowledge and understanding of policies,procedures, and regulations governing human subjectâs research and incorporatesthem in the conduct of research;
Possessesa basic awareness of the Federal regulations and guidelines governing theprotection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAAregulations), before engaging in human subjects research.
Withassistance, prepares and processes new IRB research proposals, amendments,continuing review applications and adverse event reports according toinstitutional and departmental policies and procedures and federal regulations.
Assistsin preparation and distribution of study-related documents
Communicates a basic knowledge and understanding of the managementand implementation of clinical/translational research operations,
Exhibitsthe capability to understand and follow a clinical study protocol, obtainingtraining and seeking assistance when needed, to safely and accurately performor assess required protocol procedures. Participates in the determinationof eligible candidates for study participation, assuring participants meetfulfill eligibility requirements. Recruits, screens, and enrolls new subjectsinto studies following established protocols. Uses coordination skillsand works collaboratively with study participants, other staff and departmentsto complete research protocols, including performing study procedures such asassessing participant eligibility and recruitment, arranging necessaryschedules and procedures, completing required participant registration in Epic,conducting interviews and laboratory and diagnostic studies, trackingmedication usage and other protocol specific investigational procedures.
Procuresequipment and supplies needed to fulfill project requirements
Performspackaging and ships study specimens (blood, urine, etc.) to the sponsor orlaboratory in accordance with sponsor and shipping guidelines and regulations,maintaining appropriate documentation
Follow-updata collection according to established protocols;
Communicatesand collaborates with physicians, clinic staff, and co-occurring studies in thePediatric Endocrine Clinic regarding patient recruitment, data collection,scheduling, and clinic flow
Performsdata entry in an electronic database. Prepares and maintains documents requiredto be maintained and available internally and for regulatory authorities and/orthe sponsor prior to, during and after the conduct of a clinical/translationaltrial. Participates in periodic site visits from sponsor, regulatoryauthorities and others to review research, source documentation and researchprocedures.
Participatesin meetings and communicates with research investigators and research staffregularly regarding the progress of patient recruitment and study. Maintains open and positive communications with investigators, participants,co-workers, other departments and sponsors
Withdirection assists with study completion, study closeout and archiving of studyfiles, ensuring completeness and continuity of all study data, performingongoing checks of clinical/translational data that has been entered on the casereport forms (paper or electronic) or in reports
Withsupervision, develops and manages study budgets, monitoring efficient invoicingand taking appropriate action to maintain clinical trial billing compliance
Serves as an advocate for human subjects by establishing andmaintaining communication with Investigators, research staff, sponsors,participants and representatives of professional organizations, participantadvocates, and the public responsible for, or concerned about, protections forhuman participants of research and through ongoing monitoring of trialprocesses and participants,
Participatesin the ongoing informed consent process, ensuring that human subjects, theirfamilies, and other health care providers clearly understand what is expectedof and from them in the course of participating in a clinical/translationaltrial
Encouragesopen communication with participants by providing them with contact informationand being available to answer, address or refer their calls
Withdirection, performs or instructs others in performing procedures for researchas they are described in the protocol, deviating from the protocol only when asubjectâs safety is at risk and in a timely manner reports all deviations fromthe protocol to the Principal Investigator and/or senior personnel who willdetermine if a protocol amendment or other safety reporting to appropriatefunding/regulatory agencies is required
Utilizesor obtains knowledge of disease processes to observe for and report adverseevents in a timely and accurate manner to the principal investigator and allregulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol,policies and procedures and regulations.
Actively identifies and participates in training, education anddevelopment activities to improve own knowledge and performance to sustain andenhance professional development. Pursues avenues to continue education(i.e., in-services, seminars, etc.),
Demonstratesinitiative for continuous learning, both self-directed and as evidenced byattendance of education and professional development opportunities. Activelyseeks new learning opportunities, seeing learning as part of work
Participatesin and maintains certifications, licensure and credentialing as required byVanderbilt, the department and Sponsor.
Furthersknowledge base by attending a Basic Research 101 within first three months ofemployment date.
Bachelor's Degree (or equivalent experience) and <1years 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 rankedamong 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: among the100 "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.