Clinical Research Assistant — Trial Coordination

Pinnacle Clinical Research; Austin (TX); On-site; USD 42,000 - 55,000; Full time

Job summary

Pinnacle Clinical Research in Austin, TX seeks a Clinical Research Assistant to support the Clinical Research Coordinator and the PI in administering trial activities, ensuring compliance with FDA, ICH GCP, HIPAA, and IRB requirements.

The role involves document creation, regulatory submissions, CTMS updates, recruitment support, and coordinating multiple projects while interacting with investigators, nurses, sponsors, and study staff.

Qualifications

• High school diploma or GED; or two to four years related experience and/or training.
• Clinical research certification preferred.

Responsibilities

• Assist with the creation and completion of study documents and new study prep.
• Help with regulatory submissions and maintain regulatory files.
• Serve as secondary liaison with sponsors.
• Prepare for study monitor visits as directed.
• Create reports as requested.
• Conduct study assessments with patients (AE, TA handling, scheduling, vital signs, health assessments).
• Assist with subject screening and recruitment as directed.
• Update CTMS as directed.
• Coordinate multiple projects with competing priorities and deadlines.
• Interact with physicians, nurses, staff, sponsors, lab/imaging personnel, and patients.

Skills

Oral/written comms

Organized

Detail-oriented

Medical terminology

CTMS knowledge

MS Office

Education

High school diploma or GED

2–4 years related experience

Clinical research cert preferred

Job description

Pinnacle Clinical Research in Austin, TX seeks a Clinical Research Assistant to support the Clinical Research Coordinator and the PI in administering trial activities, ensuring compliance with FDA, ICH GCP, HIPAA, and IRB requirements.

The role involves document creation, regulatory submissions, CTMS updates, recruitment support, and coordinating multiple projects while interacting with investigators, nurses, sponsors, and study staff.