Clinical Trials Data Specialist

Grade: F

One(1) year fixed term.

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 gene therapy. This position will maintain complex databases and develop tools and guidelines for data collection and integrity. 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 diseases for which there are no cures at present and the identification of curative therapies for such children will offer them new hope for health and improvement in their quality of life.

Duties Include

• Determine appropriate action to be taken for duplicate, inaccurate, or unclear information.
• Extraction and entry of required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).
• Interact closely with regulatory and quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, sponsored and Cooperative Group studies
• Assist in safety reporting
• Assist in the compilation of clinical data for reporting regulatory submissions
• - Other duties may also be assigned
• Maintaining currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback.
• Assist in design of case report forms (CRFs) for clinical studies.
• Maintaining and developing databases and spreadsheets used for clinical trials and research data collection and operations

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 $68,000.00 to $82,000.00.

Desired Qualifications

• Some knowledge of medical terminology
• Experience with Epic Systems
• Experience with Electronic Data Capture (EDC)

Education & Experience (required)

High school diploma, G.E.D., or equivalent and three years of relevant experience or a combination of education and relevant experience.

Knowledge, Skills And Abilities (required)

• Excellent computer skills.
• Strong clerical, interpersonal, and organizational skills.
• Strong attention to detail.
• Ability to exercise judgment and employ basic reasoning skills.

Certifications & Licenses

None

PHYSICAL REQUIREMENTS*:

• Occasionally use a telephone.
• - 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.
• Rarely writing by hand.
• Sitting in place at computer for long periods of time with extensive keyboarding/dexterity.