Clinical Trials Data Specialist
Stanford University School of Medicine, Palo Alto, CA, United States
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 SCGT-CTO seeks a full-time Clinical Trials Data Specialist (Data Aide 3) to 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 gene therapy. This position will maintain complex databases and develop tools and guidelines for data collection and integrity. It 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. The 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 diseases for which there are no cures at present and to identify curative therapies for such children that will offer them new hope for health and improvement in their quality of life.
Duties Include
Extraction and entry of required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).
Work with data providers to discuss and clarify data ambiguities and inconsistencies.
Determine appropriate action to be taken for duplicate, inaccurate, or unclear information.
Perform audits of own work or that of others to ensure conformance with established procedures.
Maintain and develop databases and spreadsheets used for clinical trials and research data collection and operations.
Maintain currency of research regulations, including rules concerning reporting of Serious Adverse Events (SAEs) and violations, with department training and feedback.
Interact closely with regulatory and quality assurance team to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in‑house, sponsored and Cooperative Group studies.
Assist in design of case report forms (CRFs) for clinical studies.
Assist in compilation of clinical data for reporting regulatory submissions.
May assist in safety reporting.
May provide administrative support.
Other duties may also be assigned.
Desired Qualifications
Experience with Electronic Data Capture (EDC).
Some knowledge of medical terminology.
Experience with Epic Systems.
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 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.
Education & Experience (required)
High school diploma, G.E.D., or equivalent and three years of relevant experience or combination of education and relevant experience.
Required Knowledge, Skills, and Abilities (Required)
Strong clerical, interpersonal, and organizational skills.
Excellent computer skills.
Ability to exercise judgment and employ basic reasoning skills.
Strong attention to detail.
Certifications & Licenses
None
Physical Requirements
Sitting in place at computer for long periods of time with extensive keyboarding/dexterity.
Occasionally use a telephone.
Rarely writing by 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.
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
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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 SCGT-CTO seeks a full-time Clinical Trials Data Specialist (Data Aide 3) to 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 gene therapy. This position will maintain complex databases and develop tools and guidelines for data collection and integrity. It 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. The 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 diseases for which there are no cures at present and to identify curative therapies for such children that will offer them new hope for health and improvement in their quality of life.
Duties Include
Extraction and entry of required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).
Work with data providers to discuss and clarify data ambiguities and inconsistencies.
Determine appropriate action to be taken for duplicate, inaccurate, or unclear information.
Perform audits of own work or that of others to ensure conformance with established procedures.
Maintain and develop databases and spreadsheets used for clinical trials and research data collection and operations.
Maintain currency of research regulations, including rules concerning reporting of Serious Adverse Events (SAEs) and violations, with department training and feedback.
Interact closely with regulatory and quality assurance team to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in‑house, sponsored and Cooperative Group studies.
Assist in design of case report forms (CRFs) for clinical studies.
Assist in compilation of clinical data for reporting regulatory submissions.
May assist in safety reporting.
May provide administrative support.
Other duties may also be assigned.
Desired Qualifications
Experience with Electronic Data Capture (EDC).
Some knowledge of medical terminology.
Experience with Epic Systems.
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 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.
Education & Experience (required)
High school diploma, G.E.D., or equivalent and three years of relevant experience or combination of education and relevant experience.
Required Knowledge, Skills, and Abilities (Required)
Strong clerical, interpersonal, and organizational skills.
Excellent computer skills.
Ability to exercise judgment and employ basic reasoning skills.
Strong attention to detail.
Certifications & Licenses
None
Physical Requirements
Sitting in place at computer for long periods of time with extensive keyboarding/dexterity.
Occasionally use a telephone.
Rarely writing by 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.
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
#J-18808-Ljbffr