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Organization:
Pediatric Cardiology
Job Summary:
This position will manage data management for several of Dr. Jonathan Soslow's studies, including 2 R01s, a new DOD grant, and an Industry study. He/she will review eligibility of potential enrollees for the studies and communicate with the Research Nurse to increase enrollment in the studies. They will also coordinate data entry, data lock, and data monitoring ensuring the data is thorough and complete, matching the requirements of the study protocols. They will maintain case report forms, complete documentation of case reports, an identify deviations for Dr. Soslow's studies.
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KEY RESPONSIBILITIES
• Inputs, reviews and submits eligibility and supporting documentation into the data capture systems for a portfolio of studies.
• Identifies adverse events from electronic medical records, and provides support to correctly and completely record them.
• Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
• Queries research team to clarify, reconcile and complete data issues. Identifies and resolves discrepancies per protocol.
• Prepares for and participates in internal and external clinical trial audits.
• Assist with registration and dispensation of clinical trial product using IVRS, IXRS, or IWRS.
• Maintaining appropriate and complete documentation of case report forms or electronic case report forms.
• Identifies and reports deviations for each trial.
• Reports metrics from given study load, including timeliness of entry and outstanding data.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• Database Knowledge (Novice): Knowledge and understanding of a database and how data is organized so that its contents can easily be accessed, managed, and updated.
• Quality Assurance (Novice): Understands the goal of increasing organizational productivity and individual perfo