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Vanderbilt University Medical Center Research Nurse Specialist IV, Pediatric Pulmonary in Nashville, Tennessee

JOB SUMMARY

The 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 Position

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· 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.

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Additional Key Elements/ Responsibilities:

KEY RESPONSIBILITIES

  1. Plans and implements recruitment procedures for potential participants

  2. Manages enrollment of the trial from screening to randomization to study completion

  3. Evaluates clinical data, ensures compliance with protocols and overall clinical objectives

  4. Serves as a resource for inquiries on study projects.

  5. 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

  • HasexpertknowledgeandunderstandingoftheVanderbiltpoliciesandregulationsgoverningtheprotectionofhuman subjects

  • 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.

  • Assistsinbudgetandcontractnegotiationandfacilitatesinteractionsbetweensponsorsandinstitutionaldepartments.

  • 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

  • Attendsin-servicesadvertisedbytheInstitutionalReviewBoard,ResearchSupportServices,professionalsocieties,etc.

  • 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)

  • Servesasarolemodel,mentor,supervisorandconsultantacrossteamsanddepartmentstoprovideexpertiseandshare knowledge

  • Assistswithorientationofnewresearchstaffbyservingasanavailableresource,presentingateducationalsessions, guiding new staff to attend useful educational sessions, e.g., IRBupdates

  • Developstoolstoassistnewandjuniorstaffandkeepsinformationcurrentaccordingtochangingresearchrequirements

  • Createsanenvironmentthatencouragesandsupportsself-developmentandlearningthroughregular,immediate feedback

  • Assuresthedevelopmentofstaffmembersthroughorientation,trainingprogramsandworkexperience.Strivesto developindividualizedprofessionaldevelopmentplantoguidestafftosuccess,focusingonareasneedinggrowth

  • 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.

*CA

*IND000

*NHCN

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 Conditions

Job Research Nursing

Organization: Pediatric Pulmonary 104621

Title: Research Nurse Specialist IV, Pediatric Pulmonary

Location: TN-Nashville-DOT - VCH Doctor's Office Tower

Requisition ID: 2010157

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

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