What are the responsibilities and job description for the Clinical Trials Data Specialist position at Stanford University School of Medicine?
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
Desired Qualifications
High school diploma,G.E.D.,orequivalentandthreeyearsofrelevant experienceora combinationofeducationandrelevant experience.
Required
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
None
PHYSICAL REQUIREMENTS*:
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,inconsistencies etc.
- Determineappropriateactiontobetakenforduplicate,inaccurate,orunclear information.
- Performauditsofownworkorthatofotherstoensureconformancewithestablished procedure.
- Maintaining and developing databases and spreadsheets used for clinical trials and research data collection and operations
- 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)forclinical studies.
- Assistinthecompilationofclinicaldataforreportingregulatory submissions
- Workwithdataproviderstodiscussandclarifydataambiguities,inconsistencies etc.
- Mayassistinsafety reporting
- Mayprovideadministrative support.
- - Other duties may also be assigned
Desired Qualifications
- ExperiencewithElectronicDataCapture (EDC)
- Someknowledgeofmedical terminology
- ExperiencewithEpic Systems
High school diploma,G.E.D.,orequivalentandthreeyearsofrelevant experienceora combinationofeducationandrelevant experience.
Required
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strongclerical,interpersonal,andorganizational skills.
- Excellentcomputer skills.
- Abilitytoexercisejudgmentandemploybasicreasoning skills.
- Strongattentionto detail.
None
PHYSICAL REQUIREMENTS*:
- Sittinginplaceatcomputerforlongperiodsoftimewithextensive keyboarding/dexterity.
- Occasionallyusea telephone.
- Rarelywritingby hand.
- - 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.
- Schedule: Full-time
- Job Code: 1010
- Employee Status: Regular
- Grade: F
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 108824
- Work Arrangement : Hybrid Eligible
Salary : $35 - $42