Clinical Research Associate I

About this role

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: Jul 20, 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 grant funded position with an end date of 8/31/2027 that is renewable for another year based upon work performance and progress toward research 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.

Other duties as identified by department.

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/IWRS, central labs, eCOA) on minor document or data requests. • Adheres to internal controls and reporting structure. • Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIESAttention to Detail • • Produces accurate work; catches errors early; maintains documentation precision. • Detects data/document inconsistencies during supervised SDR/SDV. • Ensures version control when preparing essential documents. • Carefully follows checklists and monitoring task guides.

• Learning Agility • Learns quickly; open to feedback; applies new knowledge rapidly. • Incorporates GCP and SOP feedback into work product. • Adapts to evolving monitoring tools (EDC, CTMS). • Asks clarifying questions early to avoid quality issues.

• Planning & Organizing • Plans tasks effectively; structures work; anticipates workload steps. • Prepares monitoring visit files ahead of deadlines. • Maintains up‑to‑date trackers for action items and study progress. • Prioritizes high‑risk data checks when instructed.

• Problem Solving • Uses structured approaches to understand and escalate issues. • Identifies root causes behind repeated documentation errors. • Distinguishes urgent vs. non‑urgent data issues. • Brings potential risks to senior staff promptly.

• Following Instructions / SOP Adherence • Strictly adheres to processes; avoids unauthorized deviations. • Follows monitoring plans and SOPs exactly as written. • Documents tasks only within approved systems. • Escalates uncertainty instead of making independent decisions.

• Interpersonal Savvy • Works effectively with site teams, CRAs, and study staff. • Communicates respectfully with CRCs and PI staff. • Receives feedback professionally. • Adapts communication style to various stakeholders.

• Written Communication • Produces clear, concise documentation aligned with GCP expectations. • Drafts clear visi

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