Clinical Research Associate I

University of Texas at Austin • UT MAIN CAMPUS, UT

7d • Onsite

About The Position

The Clinical Research Associate I (CRA I) provides foundational operational support for clinical trials under close supervision. The role assists with routine monitoring activities, data accuracy checks, document preparation, and visit scheduling to help ensure protocol adherence, participant safety verification, and data integrity. The CRA I supports remote and on-site monitoring visits conducted by senior CRAs or project leadership, including preparing visit materials, performing supervised chart reviews and source data verification, updating trackers, and collecting essential documents. The position typically reports to a Clinical Project Manager or Senior CRA and collaborates with Clinical Research Coordinators, regulatory staff, data management teams, investigational pharmacy, and study leadership.

This is a grant-funded position expected to continue through August 31, 2027, and may be renewable depending on funding availability, work performance, and progress toward research goals. It is based at the UT Main Campus in the Department of Psychiatry.

Requirements

• Bachelor’s degree in life sciences, nursing, public health, or a related field; relevant education and experience may be substituted as appropriate.
• Basic understanding of GCP and Human Subjects Protection.
• Demonstrated ability to follow SOPs, maintain accuracy, and learn quickly.
• Ability to maintain the security or integrity of critical infrastructure, as required under Texas Executive Order GA-48.
• Required application materials: resume/CV, three work references with contact information (at least one from a supervisor), and a letter of interest.

Nice To Haves

• Bachelor’s degree in life sciences, nursing, public health, or a related field with at least one year of clinical research support experience, such as CTA, CRC assistant, or research intern experience.
• Experience with EDC/CTMS systems.
• Familiarity with risk-based monitoring concepts.
• GCP training (ICH E6) and institutional human subjects training upon hire.
• IATA certification if assigned to handle or ship specimens.
• ACRP (CCRA, ACRP-CP) or SOCRA CCRP certification; not required at hire.

Responsibilities

• Assist senior CRAs in preparing for qualification, initiation, monitoring, and close-out visits.
• Participate in remote and in-person monitoring visits in a shadowing or support capacity.
• Conduct supervised source data review and basic source data verification; draft or update visit documentation for senior review.
• Perform supervised chart reviews and basic checks for data completeness, accuracy, and consistency; track queries and identify missing data or discrepancies for escalation.
• Collect, upload, organize, and track essential regulatory documents; conduct supervised ISF/TMF quality checks and prepare document packets for monitoring visits and audits.
• Perform preliminary consent-document checks for version alignment, review AE/SAE listings for completeness, and confirm eligibility criteria alignment during chart reviews, escalating concerns.
• Assist with feasibility and site assessment documentation; prepare training materials and trackers, schedule meetings, and maintain study training logs.
• Update CTMS, EDC task lists, issue logs, and monitoring visit calendars; prepare routine status updates and communicate site needs, questions, and status updates.
• Prepare investigational product accountability forms and checklists and assist with reviews of pharmacy logs and storage records.
• Assist with document retrieval and basic pre-audit file checks and participate in CAPA action tracking managed by senior team members.
• Assist with centralized data review activities for risk-based monitoring and participate in co-monitoring visits and retraining activities as assigned.
• Support SOP updates, toolkit revisions, or CAPA documentation as directed; coordinate with vendors on minor document or data requests.
• Adhere to internal controls and the reporting structure and perform related duties as required.

Benefits

• Teacher Retirement System of Texas (TRS) retirement plan eligibility, subject to the position meeting the stated hours-per-week and position-length conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level