Clinical Trials Data Specialist

🔍 School of Medicine, Stanford, California, United States

New

📁: Information Analytics

📅   : 7 hours ago Post Date

📅   : 108824 Requisition #

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 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:

• 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, inconsistencies etc.

• 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 procedure.

• Maintaining and developing databases and spreadsheets used for clinical trials and research data collection and operations

• Maintaining 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 teams 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 the compilation of clinical data for reporting regulatory submissions

• Work with data providers to discuss and clarify data ambiguities, inconsistencies etc.

• May assist in safety reporting

• May provide administrative support.

* - 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:

• Experience with Electronic Data Capture (EDC)

• Some knowledge of medical terminology

• Experience with Epic Systems

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):

• 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.