Clinical Research Associate I at The University of Texas at Austin in Austin, TX

Job description

Job Posting Title: Clinical Research Associate I ---- Hiring Department: Department of Psychiatry ---- Position Open To: All Applicants ---- Weekly Scheduled Hours: 40 ---- FLSA Status: Exempt from FLSA ---- Earliest Start Date: Oct 05, 2026 ---- Position Duration: Expected to Continue Until Aug 31, 2027 ---- Location: AUSTIN, TX ---- Job Details: General Notes Dell Medical School is seeking a Clinical Research Associate I. This is a state-funded position with an end date of August 31, 2027, renewable based on availability of funding, work performance, and progress toward goals. Purpose The Clinical Research Associate I (CRA I) provides foundational operational support for clinical trials by assisting with routine monitoring activities, data accuracy checks, document preparation, and visit scheduling under close supervision. This entry-level role helps ensure protocol adherence, participant safety verification, and data integrity by supporting site monitoring visits (remote and on-site) performed by senior CRAs or project leadership. Tasks include preparing visit materials, performing supervised chart reviews, assisting with source data verification, updating trackers, and supporting essential document collection. The CRA I typically reports to a Clinical Project Manager or Senior CRA and works closely with Clinical Research Coordinators, regulatory staff, data management teams, investigational pharmacy, and study leadership. Responsibilities Supports Site Monitoring Activities Assists senior CRAs with preparation for qualification, initiation, monitoring, and close‑out visits. Participates in remote/in‑person visits in a shadowing or support capacity. Conducts supervised source data review (SDR) and basic source data verification (SDV), prioritizing accuracy. Drafts or updates visit documentation (e.g., follow-up notes) for senior review. Assists with Data Quality & Query Support Conducts chart reviews and basic checks for completeness, accuracy, and consistency under supervision. Tracks and helps resolve queries with site staff per guidance from senior CRAs or data management. Reviews essential data listings to identify missing data or discrepancies for escalation. Supports Essential Document Management (TMF/ISF) Assists in collecting, uploading, organizing, and tracking essential regulatory documents. Conducts supervised ISF/TMF quality checks for version control and completeness. Prepares document packets for monitoring visits and audits for senior review. Aids in Participant Safety & Compliance Verification Performs preliminary checks of consent documentation for version alignment under oversight Reviews AE/SAE listings and documents for completeness and flags issues to senior CRAs. Confirms eligibility criteria alignment during chart review, escalating uncertainties Contributes to Study Start-up & Training Activities Assists with feasibility and site assessment documentation. Prepares training materials and trackers for protocol, GCP, and site-level instructions. Schedules meetings and maintains study training logs. Maintains Study Trackers, Systems & Communication Updates CTMS, EDC task lists, issue logs, and monitoring visit calendars. Prepares routine status updates for senior CRAs or PMs. Communicates site needs, questions, and status updates in a timely manner. Supports Investigational Product (IP) Documentation Prepares IP accountability forms and checklists for monitoring visits. Assists senior CRAs in reviewing pharmacy logs and storage records. Supports Audit & Inspection Readiness Assists with document retrieval and basic pre‑audit file checks. Participates in CAPA action tracking managed by senior team members. MARGINAL OR PERIODIC FUNCTIONS: Assists with centralized data review activities for risk‑based monitoring. Participates in co‑monitoring visits and retraining activities as assigned. Provides support for SOP updates, toolkit revisions, or CAPA documentation as directed. Coordinates with vendors (IVRS/IW