Remote Clinical Trials Assistant - Study Operations & Docs

Evolution Research Group; United States; Remote; USD 45,000 - 65,000; Full time

Job summary

Evolution Research Group is seeking a Clinical Trials Assistant (CTA) to support Clinical Operations on remote-based CRO projects in the United States. You will help archive master files, prepare regulatory documents, and assist with study drug release.

The role emphasizes organization, attention to detail, and teamwork, with responsibilities spanning investigator meetings, data entry, site communications, and maintaining training records.

Qualifications

• BS/BA preferred; high school diploma required.
• General knowledge of clinical research requirements, including GCP and ICH.
• Minimum of 2 years of clinical research experience; CTA experience preferred.
• Demonstrated organizational and coordination skills with attention to detail.
• Solid understanding of clinical drug development is preferred.

Responsibilities

• Assist in preparation of regulatory documents, templates, study binders and presentations; manage essential study documents.
• Assist with initial study drug release including regulatory packet review.
• Develop study-specific training materials and participate in investigator meetings.
• Interact with sites to respond to issues and handle shipments when needed.
• Monitor and track monitoring visit reports and study progress; review data at CRF, data listing and table levels.
• Collect enrollment updates and weekly reports; assist PM with meetings and minutes.
• File and QC trial master files and ensure eTMF accuracy; maintain training records.
• Update Study Contact Sheet and complete Study Plan Checklist; escalate issues when needed.
• Serve as central contact for designated project communications and related documentation.
• Enter data into clinical tracking systems; perform other related duties.

Skills

Communication

Time Management

Detail Orientation

Multitasking

Teamwork

Education

BS/BA

High School Diploma

GCP/ICH knowledge

Job description

Evolution Research Group is seeking a Clinical Trials Assistant (CTA) to support Clinical Operations on remote-based CRO projects in the United States. You will help archive master files, prepare regulatory documents, and assist with study drug release.

The role emphasizes organization, attention to detail, and teamwork, with responsibilities spanning investigator meetings, data entry, site communications, and maintaining training records.