Clinical Research Associate 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)

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.

• 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.

• 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.

• 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.

• 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.

• Prepare study reports and documentation.
• Maintain accurate records of study activities.
• Assist in the preparation of manuscripts and publications.

• 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.

• 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.

• 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.

• 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…