JOB SUMMARYThe Division of Allergy, Immunology and Pulmonary Medicine at Vanderbilt supports a robust and growing research program focused on clinical research to help understand and improve the care of children with asthma. Clinical and translational research efforts are directed at the pathogenesis of asthma in early life and approaches to asthma management throughout childhood, including multi-center federally funded clinical trials in asthma.Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist IV is responsible for assisting in the design of the clinical research, assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal/sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The RNS IV independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquiries on study projects, manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMP and other research related entities.Position Shift:· Day Shift/ 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 DiscoveryOur Nursing Philosophy:We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center’s mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.Achieve the Remarkable:Learn more about VUMC Nursing:· Nursing Careers : http://www.vumcnursingcareers.com/index.html· Benefits : http://www.vumcnursingcareers.com/benefits.html· Our Nursing Philosophy : http://www.vumcnursingcareers.com/philosophy.html· Our Nursing Leadership : http://www.vumcnursingcareers.com/leadership.html· Shared Governance : http://www.vumcnursingcareers.com/shared-governance.html· Education & Professional Development : http://www.vumcnursingcareers.com/professional-development.html· Life In Nashville : http://www.vumcnursingcareers.com/nashville.htmlVUMC Nursing : http://www.mc.vanderbilt.edu/root/vumc.php?site=vanderbilt-nursingVUMC 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 RESPONSIBILITIESPlans and implements recruitment procedures for potential participants
Manages enrollment of the trial from screening to randomization to study completion
Evaluates clinical data, ensures compliance with protocols and overall clinical objectives
Serves as a resource for inquiries on study projects.
Manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMP and other research related entities.
Tasks include, but are not limited to:Participatesinthedeterminationofeligiblecandidatesforstudyparticipation.Strivestoensurestudiesarecompletedin a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
Knowledge and understanding of policies, procedures, and regulations governing human subject's research. Proficiently preparesandprocessesnewresearchproposals,amendments,continuingreviewapplications,adverseevents,budgets, andD&Haccountsaccordingtoinstitutionalanddepartmentalpoliciesandproceduresandfederalregulations
Functionsasadepartmentalresourceregardingclinicaltrialsoperationse.g.,theoperationsoftheVanderbilt Institutional Review Board and its requirements for the protection of humansubjects
MaintainsaclearunderstandingoftheFederalregulationsgoverningtheprotectionofhumansubjects,e.g.,FDA,OHRP, GCP/ICH guidelines, and HiPAAregulation
Knowledge and understanding of the management and implementation of clinical trialoperations
Capability to understand, implement, and follow a clinical study protocol and is able to conduct multiple studies independently(abletoidentifywhentrainingisneededtosafelyandaccuratelyperformorassessrequiredprocedures. Problem solves when needed to acquire or deliver suchtraining).
Independentlypreparesandmaintainscriticaldocumentsrequiredtobemaintainedandprovidedtothesponsorduring and after the conduct of a clinical trial. Assists with study completion, data lock, study closeout and archiving of study files.
Collaboratively directs and participates in study teammeetings
Maintainsopenandpositivecommunicationswithinvestigators,participants,co-workers,otherdepartmentsand sponsors. Collaborates with other departments to seek solutions to global researchconcerns.
Digestscomplexclinicalinformationtodetermineifdocumentationisaccurate,complete,andtoensureprocedures contain appropriate safeguards. Understands standard of care versus research and continually assesses need for additionalprotectionsfortheprotectionofresearchparticipantsandtheappropriatenessofresearchdata.
Proactivelyinvolvedinqualityimprovementthroughongoingassessmentandthroughtheidentificationofissuesand planning and evaluation of qualityimprovement.
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff,representativesofprofessionalorganizations,participantadvocates,andmembersofthepublicresponsiblefor,or concerned about, protections for human participants of research
Assessesandevaluatespotentialparticipantspertinentmedicalandhistoricalinformationtoensureonlyappropriate subjects are enrolled in clinicaltrials
Utilizes nursing skills to complete all research protocols, including patient recruitment, screening, scheduling and organizingofstudyvisits,enrollment,assessments,interviews,laboratoryanddiagnosticstudies,medicationdispensing and other protocol specific investigationalprocedures
Independentlyusesanddocumentsthenursingprocesstoplan,deliverandevaluategoalfocused,individualized,safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
Participatesintheongoinginformedconsentprocess,ensuringthathumansubjectsclearlyunderstandwhatisexpected of and from them in the course of participating in a clinicaltrial
Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject'ssafetyisatriskandreportingalldeviationstothePrincipalInvestigatorwhowilldetermineofaprotocol amendment or other safety assessments arerequired
Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specificcareasitrelatestouncomplicatedandcomplicatedresearchparticipants,seekingassistancewhenneeded
Utilizesknowledgeofdiseaseprocessestoobserveforandreportadverseeventsinatimelyandaccuratemannertothe principal investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures andregulations
Conducts literature searches as appropriate for new studies and at the time of continuing review. Literature searches are helpfultokeepup-to-dateintheresearchfieldofstudyinordertodetermineifsignificanthistoricalornewfindingsexist that may impact the risk/benefit ratio of the researchparticipant
Actively identifies and participates in training, education, and development activities to improve own knowledge and performancetosustainandenhanceownprofessionaldevelopment.Pursuesavenuestoensureawarenessofthelatest information available to nurses conducting clinical research, forexample
Reviews the Research Support Services website to obtain information regarding available and required in-services, requiredcertificationsandtoobtainimportantupdates.HelpsprovideupdatesandideastoRSSgroupforinclusionon their website. Willing to share tools, forms, and techniques withothers
Attends the Clinical Research Staff Council monthlymeetings
Demonstratesinitiativeinself-directedlearning,asevidencedbyattendanceofprofessionaldevelopmentopportunities. Actively seeks new learning opportunities. Sees learning as part ofwork
Assumesresponsibilityforcontinuouslearning,engaginginaminimumof20hoursofeducationalactivitiesannuallyor pursuing an advanced academic education orcertifications
Participates and presents in local, national and internationalconferences
Actively participates in publishingopportunities
Develops and achieves personal and professionalgoals
Participatesinandmaintainsprofessionalcertifications,licensureandcredentialingasrequiredofnursesemployedat Vanderbilt (i.e., CPRcertification)
Assistswithorientationofnewresearchstaffbyservingasanavailableresource,presentingateducationalsessions, guiding new staff to attend useful educational sessions, e.g., IRBupdates
Exhibitsstrongleadershipskills.Applieskeyconceptsoffacilitativeleadership.Assignsandreviewswork;effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes projects in an efficientmanner
Position Qualifications:Graduate of an approved discipline specific program (or equivalent experience) (Required)10+ years experience (Required)Registered Nurse (Required)Discipline specific certification in accordance with department requirements. Can be substituted with advanced degree.CAIND000NHCNPhysical 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 Research NursingOrganization: Pediatric Pulmonary 104621Title: Research Nurse Specialist IV, Pediatric PulmonaryLocation: TN-Nashville-DOT - VCH Doctor's Office TowerRequisition ID: 2010157Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.