Clinical Research Associate I Full-time NEW

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 02/28/2027, renewable based upon availability of funding, work performance, and progress toward research goals. This position will provide research assistance/support for research projects in the Lippard Lab in the Department of Psychiatry at UT Austin working as part of a team of faculty, staff, graduate students, and undergraduate assistants. Weekend and evening work will be required.

The Clinical Research Associate I (CRA I) provides foundational operational support for clinical trials and research studies 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 study visits. Tasks include preparing visit materials, performing data reviews, assisting with source data verification, updating trackers, supporting essential document collection, and conducting clinical assessments, behavioral assessments (including during alcohol administration sessions), and collecting MRI data. The CRA I works closely with Clinical Research Coordinators data management teams, and study leadership.

Responsibilities:

• Supports Study Visit Activities
• Assists senior CRAs with preparation for study visits.
• Participates in in-person visits in a shadowing or support capacity.
• Plans/supports travel for study participants
• Conducts phone screens, clinical assessments, behavioral data collection, and MRI data collection associated with study visits.
• 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 data 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 on discrepancies for escalation.
• Aids in Participant Safety & Compliance Verification
• Performs preliminary checks of consent documentation for version alignment under oversight
• Reviews and reports AE/SAE listings and documents for completeness and flags issues to senior CRAs.
• Confirms eligibility criteria alignment
• 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 visit calendars.
• Prepares routine status updates for senior CRAs or PMs.
• Communicates site needs, questions, and status updates in a timely manner.

Other Job Duties may apply as assigned

Marginal or Periodic Functions:

• • Assists with centralized data review activities for risk-based monitoring and data accuracy/completeness.
  • Participates in audit visits and retraining activities as assigned.
  • Provides support for SOP updates or toolkit revisions as directed.
  • Coordinates with vendors (e.g., 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 task guides.
• • Learning Agility
  • Learns quickly; open to feedback; applies new knowledge rapidly.
  • Incorporates GCP and SOP feedback into work product.
  • Asks clarifying questions early to avoid quality issues.
• • Planning & Organizing
  • Plans tasks effectively; structures work; anticipates workload steps.
  • Prepares study 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 visit notes and status updates.
  • Writes concise query explanations.
  • Ensures accuracy before submitting documentation for review.

Education & Experience

Minimum Qualifications:

Requires a Bachelor's Degree in life sciences (e.g., neuroscience or psychology), nursing, public health or a related field.

• Basic understanding of GCP/Human Subjects Protection
• Demonstrated ability to follow SOPs, maintain accuracy, and learn quickly.
• Prior experience in research in human populations
• Relevant education and experience may be substituted as appropriate.

Preferred Qualifications:

Bachelor's Degree in life sciences (e.g., neuroscience or psychology), nursing, public health or a related field with at least 1 year of experience in clinical research support (CTA, CRC assistant, research intern). Familiarity with clinical assessments and/or MRI data collection

Licenses, Registrations or Certifications

Required: None

Preferred: GCP training (ICH E6) and institutional human subjects training upon hire.