Job Description

Summary

The Research Assistant supports Study Coordinators in research study activities, ensuring adherence to study protocols, regulatory requirements, and company policies. Responsibilities include recruiting and coordinating research subjects, maintaining records and systems, and performing patient care per study protocols and PI direction.

Duties and Responsibilities

• Ensure compliance with company policies, SOPs, FDA, and GCP guidelines.
• Assist in site organization, EDC entry, and data management.
• Develop and maintain study documentation, logs, and source documents.
• Order, inventory, and manage research and lab supplies.
• Recruit and schedule study subjects, ensuring protocol compliance and enrollment targets.
• Collect laboratory specimens, perform EKGs, and process lab shipments.
• Facilitate informed consent and patient communications.
• Prepare and update research binders, logs, and the CTMS system.
• Assist with regulatory submissions to IRBs and sponsors.
• Provide training to staff and attend Site Initiation Visits (SIVs).
• Perform research study visits, vital assessments, and ensure data confidentiality.
• Occasionally travel for company or sponsor meetings.

Education and Experience

• High School Diploma.
• 1+ years of on-the-job research assistant training.

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