Clinical Research Associate I

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.

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.

• 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/ABILITIES Attention 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…