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, renewable for another year based upon work performance and progress toward research goals. Purpose 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. Responsibilities 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. 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, and Abilities 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 elevate 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. Required Qualifications Minimum: 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 one year of experience in clinical research support (CTA, CRC assistant, research intern). Experience with EDC/CTMS systems. Familiarity with risk‑based monitoring concepts. Licenses, Registrations or Certifications Required – None Preferred GCP training (ICH E6) and institutional human subjects training upon hire. IATA certification if handling/shipping specimens (when assigned). ACRP or SOCRA certification (not required at hire). Benefits Salary Range: $40,000 + depending on qualifications. Working Conditions: Standard office equipment; repetitive use of a keyboard. Equal Opportunity Employer University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions. Pay Transparency The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Employment Eligibility Verification If hired, you will be required to complete the federal Employment Eligibility Verification I‑9 form within the first three days of employment. Failure to do so will result in loss of employment at the university. E‑Verify United States Department of Homeland Security requires the use of E‑Verify to check the work authorization of all new hires. The University’s company ID number for E‑Verify is 854197. Background Checks A criminal history background check will be required for finalists under consideration for this position. #J-18808-Ljbffr The University of Texas at Austin