Clinical Research Assistant

Job Overview

1. Rx Lens Order Management & Input

• Accurately input complex prescription lens data into ordering systems.
• Verify lens parameters
• Communicate with optical labs to troubleshoot order delays or specification discrepancies.
• Verify incoming lenses

2. Tracking & Inventory Control

• Maintain a real-time tracking log of all pending, shipped, and received lens orders.
• Device accountability: Manage physical and digital inventory of frames and lenses
• Conduct regular audits to ensure inventory levels align with study recruitment targets.

3. Clinical Documentation & Assistant Support

• Support the Lead Coordinator in maintaining the Trial Master File (TMF) and site-specific regulatory binders.
• Assist in the preparation and filing of IRB (Institutional Review Board) submissions, amendments, and continuing reviews.
• Data entry, data collection, and query resolution
• Ensure all participant "Source Documentation " is accurate, legible, and compliant with ALCOA+ principles.

4. Regulatory Compliance

• Facilitate the Informed Consent process for study participants, ensuring all ethical and regulatory requirements are met.
• Adhere strictly to GCP (Good Clinical Practice) and HIPAA guidelines regarding participant privacy and data integrity.
• Required Qualifications
• Experience: Minimum of 1 year of experience in clinical research or similar regulatory role.
• Regulatory Knowledge: Proven experience working with IRBs, managing the consenting process, and maintaining clinical study documentation.
• Technical Accuracy: High level of comfort with data entry where precision is critical (familiarity with ophthalmic prescriptions is a plus).
• Organization: Exceptional tracking skills; ability to manage high volumes of hardware/inventory without loss of data integrity.
• Communication: Strong professional presence for participant interaction and clear technical communication with lab partners.
• GCP certification

Preferred Skills

• Familiarity with optical and ophthalmic terminology
• Previous experience in a device-based clinical trial environment

Pay: $25.00 - $30.00 per hour

Work Location: In person