Remote Clinical Trials Assistant - Drive Study Timelines

Lotus Clinical Research, LLC; Idaho; Hybrid; USD 45,000 - 65,000; Full time

Job summary

Lotus Clinical Research, LLC is seeking a Clinical Trials Assistant (CTA) for a remote, full-time role in the United States. The CTA will support Clinical Operations to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

The role includes archiving, organizing master files, preparing regulatory documents, coordinating investigator meetings, and tracking study progress.

Qualifications

• BS/BA preferred; high school diploma or equivalent required.
• General knowledge of clinical research requirements including GCP/ICH.
• Minimum 2 years of clinical research experience; CTA experience preferred but not required.
• Demonstrated organizational and coordination skills with attention to detail.
• Solid understanding of clinical drug development is preferred.

Responsibilities

• Support Clinical Operations to ensure studies are completed on time and within budget.
• Archive and organize clinical trial master file documents and generate filing indexes.
• Assist with preparation of regulatory documents, study binders, and study communications.
• Assist with initial study drug release including regulatory packet review.
• Prepare study-specific training materials and participate in investigator meetings.
• Interact with sites to respond to issues and manage shipments as needed.
• Monitor and track monitoring visit reports and study progress updates.
• Assist in data review at case report form, data listing, and report table levels.
• Record enrollment updates and assist PM with meeting setup and minutes.
• File and QC study master files and update Study Contact Sheet.

Education

BS/BA preferred

High school diploma required

Job description

Lotus Clinical Research, LLC is seeking a Clinical Trials Assistant (CTA) for a remote, full-time role in the United States. The CTA will support Clinical Operations to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

The role includes archiving, organizing master files, preparing regulatory documents, coordinating investigator meetings, and tracking study progress.