Clinical Research Associate I at Dell Medical School

About the Position

Clinical Research Associate I Job at Dell Medical School, Austin, TX

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.

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.

Requirements

• Education & Experience
  • Bachelor's Degree in life sciences, nursing, public health, or a related field.
  • Basic understanding of GCP/Human Subjects Protection.
  • Demonstrated ability to follow SOPs, maintain accuracy, and learn quickly.
  • Relevant education and experience may be substituted as appropriate.
• Preferred Qualifications
  • At least 1 year of experience in clinical research support (CTA, CRC assistant, research intern).
  • Experience with EDC/CTMS systems.
  • Familiarity with risk-based monitoring concepts.

Nice to Have

• GCP training (ICH E6) and institutional human subjects training upon hire.
• IATA certification if handling/shipping specimens (applies only if assigned).
• ACRP (CCRA, ACRP-CP) or SOCRA CCRP certification (not required at hire).

We Offer

• Competitive salary: $40,000+ depending on qualifications.
• Standard office equipment.
• Repetitive use of a keyboard.

About the Company

Dell Medical School is a part of the University of Texas at Austin, dedicated to transforming healthcare through innovative education, research, and patient care.

Application Instructions

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.

Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.