Clinical Research Coordinator Associate

The PediatricVascular Laboratoryled byDr.Tierneyat Stanford Universityisseeking a ClinicalResearch Coordinator Associate to perform duties related tothe coordination of clinical studies.Coordinatemoderatelycomplex aspects of one or more clinical studies.Work under close direction of the principal investigator and/or study coordinator/supervisor.

 Duties include:

·         Serveasprimarycontactwith research participants,sponsors,andregulatoryagencies.Coordinatestudiesfrom startup through close-out.

·         Determineeligibilityofandgather consent from studyparticipantsaccordingtoprotocol.Assistin developingrecruitment strategies.

·         Coordinatecollectionofstudyspecimensandprocessing.

·         Collectandmanagepatientandlaboratorydatafor clinicalresearch projects.Manageresearch projectdatabases, develop flow sheets and other study related documents, and complete study documents/case report forms.

·         Ensurecompliancewithresearchprotocols, andreviewandauditcasereportformsfor completionandaccuracywithsource documents.Prepareregulatory submissions, and ensure institutional Review Board renewals are completed.

·         Assemblestudykitsfor studyvisits,monitor schedulingofproceduresandcharges, coordinatedocuments,andattend monitoring meetings with sponsors, acting as primary contact.

·         Monitor expendituresandadherencetostudybudgetsandresolvebillingissuesin collaboration with financeand/or management staff.

·         Interact with theprincipalinvestigatorregularly, ensuringpatientsafetyandadherencetoproper studyconduct.Assist with onboarding of a new team member.

·         Ensureessentialdocumentationandrecording ofpatientandresearch datainappropriatefilesper institutionalandregulatory requirements.

·         Participateinmonitorvisitsandregulatoryaudits.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. The pay range for this position working in the California Bay area is between $27.88 to $36.54 based on commensurate experience and background.

DESIREDQUALIFICATIONS:

Meticulous,responsible,detail-oriented,comfortableinteractingwithpatients/participantsandmulti-tasking,solution-oriented. Prior experience with consent/assenting and interviewing research subjects is a plus.

EDUCATION&EXPERIENCE(REQUIRED):

Twoyear collegedegreeandtwoyearsrelatedworkexperienceoraBachelor’sdegreeinarelatedfieldoran equivalent combination of related education and relevant experience.

KNOWLEDGE,SKILLSANDABILITIES(REQUIRED):

·         Stronginterpersonalandskills.

·         Attentiontodetailandabilitytomulti-task

·         Proficiencywithtechnologyincludingzoom,Microsoftword,excel,andpowerpoint.

·         Experiencewithresearch protocolsandregulatoryor governingbodies, which includeHIPAAregulations,Institutional Review Board requirements, and Good Clinical Practices.

·         Knowledgeofmedicalterminology.

·         ExperiencewithRedCAPdatabase

FluencyinSpanish(optional)

CERTIFICATIONS&LICENSES:

SocietyofClinicalResearchAssociatesorAssociationofClinicalResearchProfessionalscertificationispreferred.

·         Frequentlystand,walk,twist,bend,stoop,squatandusefinelight/finegrasping.

·         Occasionallysit,reach aboveshoulders,performdesk based computer tasks, useatelephoneand writebyhand,lift,carry, push, and pull objects that weigh up to 40 pounds.

·         Rarelykneel, crawl, climbladders,grasp forcefully, sortandfilepaperwork or parts,rarelylift,carry, push,and pullobjects that weigh 40 pounds or more.

*-Consistent withitsobligationsunderthelaw, theUniversitywill provide reasonableaccommodationtoanyemployeewitha disability who requires accommodation to perform the essential functions of his or her job.

AdditionalPHYSICALREQUIREMENTS:

WORKINGCONDITIONS:

Occasionaleveningandweekendhoursbasedonresearchrequirements

~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~