Job Information
Stanford University Clinical Trials Data Specialist in Stanford, California
Clinical Trials Data Specialist
School of Medicine, Stanford, California, United States
New
Information Analytics
Post Date 4 days ago
Requisition # 108824
Grade:F
The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) provides comprehensive project support and clinical trial management resources to Stanford Investigators specializing in cellular and gene therapies. The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) seeks a full-time a Clinical Trials Data Specialist (Data Aide 3) enter data from a source document into a computer system and verify entries for accuracy and completeness to support clinical research trials in cell and genetherapy. Thispositionwillmaintaincomplexdatabasesanddeveloptoolsandguidelinesfordatacollectionandintegrity. This position may also assist the clinical trials team with safety reporting across studies. Work is performed by exercising independent judgment and initiative in performing tasks. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
The mission of the SCGT-CTO is to translate basic discoveries into innovative therapeutics to treat children with debilitating diseasesfor which therearenocuresatpresentandtheidentification ofcurativetherapiesfor such children willoffer themnew hope for health and improvement in their quality of life.
Duties include:
• Extractionandentryofrequired clinical data frommedicalrecords and patientresearch charts/reportstoClinicalResearch Forms (eCRFs/CRFs).
• Workwithdataproviderstodiscussandclarifydataambiguities,inconsistenciesetc.
• Determineappropriateactiontobetakenforduplicate,inaccurate,orunclearinformation.
• Performauditsofownworkorthatofotherstoensureconformancewithestablishedprocedure.
• Maintaining anddevelopingdatabasesand spreadsheetsused forclinicaltrialsandresearchdatacollectionandoperations
• Maintainingcurrencyofresearchregulations includingrulesconcerningreporting ofSerious AdverseEvents(SAEs)and violations with department training and feedback.
• Interact closelywith regulatoryand qualityassuranceteamstoensuredataaccuracyon ClinicalResearch Forms (eCRFs/CRFs) prior to submission for in-house, sponsored and Cooperative Group studies
• Assistindesignofcasereportforms(CRFs)forclinicalstudies.
• Assistinthecompilationofclinicaldataforreportingregulatorysubmissions
• Workwithdataproviderstodiscussandclarifydataambiguities,inconsistenciesetc.
• Mayassistinsafetyreporting
• Mayprovideadministrativesupport.
* - Other duties may also be assigned
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 $35.30 to $41.74 hourly.
DESIRED QUALIFICATIONS:
• ExperiencewithElectronicDataCapture(EDC)
• Someknowledgeofmedicalterminology
• ExperiencewithEpicSystems
EDUCATION & EXPERIENCE (REQUIRED):
High school diploma,G.E.D.,orequivalentandthreeyearsofrelevant experienceora combinationofeducationandrelevantexperience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Strongclerical,interpersonal,andorganizationalskills.
• Excellentcomputerskills.
• Abilitytoexercisejudgmentandemploybasicreasoningskills.
• Strongattentiontodetail.
CERTIFICATIONS & LICENSES:
None
PHYSICAL REQUIREMENTS*:
• Sittinginplaceatcomputerforlongperiodsoftimewithextensivekeyboarding/dexterity.
• Occasionallyuseatelephone.
• Rarelywritingbyhand.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Additional Information
Schedule: Full-time
Job Code: 1010
Employee Status: Regular
Grade: F
Department URL: http://pediatrics.stanford.edu/
Requisition ID: 108824
Work Arrangement : Hybrid Eligible