The Department of Psychiatry at The University of Texas at Austin is seeking a Clinical Research Associate I to assist in the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory requirements and study protocols. The role involves site management, data collection, and maintaining data integrity for research studies.
Requirements
- Experience with electronic data capture systems (e.g., REDCap).
- Familiarity with IRB processes and human subjects protection standards.
- Experience with statistical software (e.g., R, SAS, SPSS).
- Ability to abstract data from medical records and manage complex databases.
- Completion of Human Subjects Protection Training.
- Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
- Double-checks work for errors, maintains organized records, and follows detailed procedures.
Responsibilities
- 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.
- Ensures compliance with study protocols and regulatory requirements.
- Administers questionnaires, collect medical history, and perform study procedures.
- Obtains informed consent and ensure participant safety throughout protocol procedures.
- Collects and verifies data from clinical sites.
- Ensures accurate and timely data entry into electronic data capture systems (e.g. REDCap).
- Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.
Other
- Requires a Bachelor's Degree in life sciences, nursing, or a related field.
- 1 year of relevant clinical research experience.
- Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in
- Clinical research experience preferably involving pediatric or neurodevelopmental populations.
- Strong written and verbal communication skills.
