Surgical Clinical Research Coordinator

The University of Texas at Austin; Utah; On-site; USD 53,000 - 75,000; Full time

Job summary

The University of Texas at Austin is seeking a Clinical Research Coordinator in the Department of Surgery and Perioperative Care. You will coordinate start‑up, recruit and consent participants, and manage visits and data in compliance with ICH‑GCP and FDA/IRB requirements.

Responsibilities include regulatory maintenance, IP tracking, and collaboration with sponsors, CRAs, and clinical teams to ensure quality data and participant safety.

Qualifications

• Bachelor’s degree in health, life science, or related field.
• 3 years of clinical research coordination or closely related human-subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).
• Ability to work comfortably in a clinical environment, including the operating room.
• Adherence to established work schedules and reliable attendance.
• Master’s degree preferred; additional certifications in GCP/IRB are advantageous.

Responsibilities

• Coordinates study start‑up and feasibility, assists with budget/coverage analysis inputs and study calendars.
• Recruits, screens, and consents participants per FDA/IRB guidelines.
• Plans and conducts protocol‑specified assessments and visits with data entry into EDC/CTMS.
• Maintains regulatory binders/eTMF and submits amendments and continuing reviews.
• Ensures participant safety, monitors AEs/SAEs, and escalates medical concerns as needed.
• Performs data quality checks and supports on-site/remote monitoring and audits.

Skills

ICH-GCP & FDA/IRB guidance

EDC/CTMS proficiency

Regulatory compliance

Effective communication

Education

Bachelor’s degree in health, life science, or related field

Master’s degree preferred

Tools

Epic

EDC/CTMS

Job description

The University of Texas at Austin is seeking a Clinical Research Coordinator in the Department of Surgery and Perioperative Care. You will coordinate start‑up, recruit and consent participants, and manage visits and data in compliance with ICH‑GCP and FDA/IRB requirements.

Responsibilities include regulatory maintenance, IP tracking, and collaboration with sponsors, CRAs, and clinical teams to ensure quality data and participant safety.