Clinical Research Assistant: Frontline Trials Support

Pinnacle Clinical Research- A Summit Solution; Austin (TX); On-site; USD 46,000 - 65,000; Full time

Job summary

Pinnacle Clinical Research- A Summit Solution in Austin, TX seeks a candidate to support the Clinical Research Coordinator and the principal investigator with study activities, patient coordination, and regulatory documentation. You will handle scheduling, data entry, and reporting while maintaining confidentiality.

Responsibilities include preparing study materials, assisting with regulatory submissions, liaising with sponsors and sites, and ensuring compliance with FDA, ICH-GCP, HIPAA, and IRB

Qualifications

• High school diploma or GED; or 2–4 years related experience
• Knowledge of medical terminology
• Experience with clinical trial documentation and regulatory submissions

Responsibilities

• Assist with study documents and new study prep
• Maintain regulatory files and assist with submissions
• Serve as secondary liaison with sponsors
• Prepare for monitor visits and create reports
• Conduct patient assessments and coordinate visits
• Support subject screening and recruitment
• Update CTMS and other study systems
• Coordinate multiple projects with competing priorities

Skills

Oral communication

Written communication

Organizational skills

Attention to detail

Medical terminology

Diplomatic communication

Flexibility with changing priorities

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

Browsers (IE/Chrome/Firefox)

CTMS

eCRF systems

Job description

Pinnacle Clinical Research- A Summit Solution in Austin, TX seeks a candidate to support the Clinical Research Coordinator and the principal investigator with study activities, patient coordination, and regulatory documentation. You will handle scheduling, data entry, and reporting while maintaining confidentiality.

Responsibilities include preparing study materials, assisting with regulatory submissions, liaising with sponsors and sites, and ensuring compliance with FDA, ICH-GCP, HIPAA, and IRB