Clinical Research Associate

Dell Medical School is seeking a Clinical Research Associate I. This is a grant-funded position with an end date of 8/31/2027, renewable for another year based upon work performance and progress toward research goals.

The Clinical Research Associate 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.

• Supports Site Monitoring Activities
  • Assists senior CRAs with preparation for qualification, initiation, monitoring, and close‑out visits.
  • Participates in remote or in‑person visits in a shadowing or support capacity.
  • Conducts supervised source data review and basic source data verification, prioritizing accuracy.
  • Drafts or updates visit documentation 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.
  • 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 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.
  • 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.

• 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.

• Attention to Detail
  • Produces accurate work; catches errors early; maintains documentation precision.
  • Detects data/document inconsistencies during supervised source data review.
  • 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.
  • 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…