Clinical Research Associate I at The University of Texas at Austin Austin, TX

Clinical Research Associate I Department: Psychiatry, University of Texas at Austin Location: Austin, TX Weekly Hours: 40 Full Time: Exempt Start Date: Immediately Position Duration: Until August 31, 2026 (grant‑funded, renewable) Job Overview Assist in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. The Clinical Research Associate I (CRA I) will work independently or with general direction at the fully operational journey level to execute, manage, and coordinate research protocols as directed by the Principal Investigator (PI). The role involves site management, data collection, and maintaining the integrity of clinical data. Responsibilities Site Management Conduct site initiation, monitoring, and close‑out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution. Ensure compliance with study protocols and regulatory requirements. Manage site performance and resolve issues. Administer questionnaires, collect medical history, and perform study procedures. Maintain rapport with participants to ensure retention and address concerns. Obtain informed consent and ensure participant safety throughout protocol procedures. Coordinate with affiliated departments and external collaborators. Data Collection and Management Collect and verify data from clinical sites. Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap). Review and resolve data queries. Assist with manuscript and grant preparation, including opportunities for authorship. Maintain and update study databases and data collection forms. Regulatory Compliance Ensure adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines. Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites. Prepare and maintain regulatory documents. Coordinate with ethics committees to safeguard participant rights. Participate in internal and external audits and protocol reviews. Participant Recruitment and Retention Evaluate medical records and perform screenings to identify eligible study participants. Assist in screening and enrolling study participants. Maintain communication with participants to ensure retention. Address participant concerns and queries. Reporting and Documentation Prepare study reports and documentation. Maintain accurate records of study activities. Assist in the preparation of manuscripts and publications. Marginal or Periodic Functions Conduct literature reviews to support study design and protocol development. Assist in training new site staff and research team members. Participate in internal and external audits. Support the development of study protocols and case report forms. Attend conferences and workshops to stay updated on industry trends. Adhere to internal controls and reporting structure. Perform related duties as required. Knowledge, Skills, and Abilities Double‑check work for errors, maintain organized records, and follow detailed procedures. Write clear and concise reports, actively listen to others, and present information effectively. Analyze information, develop solutions, and implement corrective actions. Share information, support team decisions, and contribute to team success. Prioritize tasks, set realistic deadlines, and use time efficiently. Required Qualifications Bachelor's Degree in life sciences, nursing, or a related field. One year of relevant clinical research experience. Familiarity with IRB processes and human subjects protection standards. Experience with electronic data capture systems (e.g., REDCap). Relevant education and experience may be substituted as appropriate. Preferred Qualifications Master's Degree in life sciences, nursing, or a related field with at least two years of experience. Clinical research experience involving pediatric or neurodevelopmental populations. Experience with statistical software (e.g., R, SAS, SPSS). Prior experience presenting research findings or contributing to publications. Completion of Human Subjects Protection Training. Experience working with children and families affected by neurodevelopmental disorders. Strong written and verbal communication skills. Ability to abstract data from medical records and manage complex databases. Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP). Salary $40,000 + depending on qualifications Working Conditions Standard office conditions with occasional use of a keyboard at a workstation. Occasional weekend, overtime, and evening work to meet deadlines. Occasional interstate, intrastate, and international travel. Position is 100% on campus with expectation to report to work on-site during scheduled work week. Equal Opportunity Employer The 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. Employees who have access to compensation information as part of their essential job functions cannot disclose pay to individuals who do not otherwise have access, 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. E‑Verify All new hires are checked for work authorization via E‑Verify (University ID 854197). Compliance Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). Required notifications and resources are available through University Compliance Services. #J-18808-Ljbffr The University of Texas at Austin