Position Summary:

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

• Assists in identifying eligible subjects.
• Arrange study visits and provides instructions.
• Assists in creating and updating case report forms and/or source documents. Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and sponsor.
• Abstracts data from medical records and enters medical information/data onto protocol specific case reports forms, study flow sheets and other required study forms.
• 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.
• Prepares abstracted/coded data for computer processing/analysis. Attends investigator meetings.
• Processes specimens.

Knowledge, Skills and Abilities:

• Bachelor 's degree required, preferably in a related field, with 1-3 years experience in clinical research -or- Minimum of 1 year experience as a Clinical Research Associate.
• Familiarity and experience with FDA and IRB regulatory requirements is preferred