Clinical Research Associate I

The University of Texas at Austin’s Dell Medical School is hiring a Clinical Research Associate I in the Department of Psychiatry. The role provides supervised operational support for clinical trials, including monitoring activities, data quality checks, essential document management, participant safety and compliance verification, and study coordination.

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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
• Prepares IP accountability forms and checklists for monitoring visits
• Assists senior CRAs in reviewing pharmacy logs and storage records
• 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

Preferred

• Bachelor's Degree in life sciences, nursing, public health or a related field with 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
• 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)
• Bachelor's Degree in life sciences, nursing, public health or a related field with at least 1 year of experience in clinical research support (CTA, CRC assistant, research intern).
• Life Sciences
• Nursing
• Public Health
• Clinical Research Support
• EDC Systems
• CTMS Systems
• Risk-Based Monitoring
• GCP Training (ICH E6)
• Human Subjects Research Training
• IATA Certification
• ACRP Certification CCRA
• ACRP Certification ACRP-CP
• SOCRA CCRP Certification

Benefits

• Eligibility for the Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Company

• Public university offering higher education and research.
• Austin, Texas, USA
• http://www.texasenterprise.utexas.edu/
• Founded in 1883
• 10001+ employees

Qualifications

• Requires a 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
• According to Executive Order No. GA-48 of the State of Texas: for all positions that research, work on, or have access to critical infrastructure as defined in Section 117.001(2), Business and Commerce Code, it is required that both candidates for employment and employees have the ability to maintain the security or integrity of the infrastructure
• Bachelor's Degree in life sciences, nursing, public health or a related field with 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
• 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)

Required skills

• Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Human Subjects Protection, Risk-Based Monitoring, Standard Operating Procedures (SOPs)

Preferred skills

• Experience with EDC/CTMS systems, Familiarity with risk‑based monitoring concepts

Experience

• 1+ years