Position Summary:

Collects and manages patient and laboratory data for clinical research projects. Screens and oversees the recruitment of subjects.

Essential Job Functions:

• Arrange study visits and provides instructions.
• Assists in creating and updating case report forms and/or source documents.
• Abstracts data from medical records and enters medical information/data onto protocol specific case reports forms, study flow sheets and other required study forms.
• Assists in identifying eligible subjects.
• Creates and performs QA/QC procedures, orders supplies for data collection, develops worksheets/tools for collecting patient data and enters data electronically via web based systems.
• Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and sponsor.
• Prepares abstracted/coded data for computer processing/analysis. Attends investigator meetings.
• Processes specimens.
• Maintains investigator/sponsor files in accordance with FDA and Good Clinical Practice (GCP) Guidelines.