Clinical Research Associate I

The University of Texas at Austin•Austin, UT

3d•Onsite

About The Position

Dell Medical School is seeking a Clinical Research Associate I. This is a grant funded position with an end date of August 31, 2027. Purpose The Clinical Research Associate I (CRA I) will conduct interviews and support research project management for two different mental health studies. One study is focused on the impact of a traumatic event on a child’s mental health, and the other study is focused on the cognitive impact of early psychosis on adolscent and young adults who are within two years of their psychotic disorder diagosnis. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.

Requirements

Requires a Bachelor's Degree in psychology, social work, public health, or a related field.
at least 1 year(s) of experience in clinical research.
Relevant education and experience may be substituted as appropriate.
Double-checks work for errors, maintains organized records, and follows detailed procedures.
Writes clear and concise reports, actively listens to others, and presents information effectively.
Analyzes information, develops solutions, and implements corrective actions.
Shares information, supports team decisions, and contributes to team success.
Prioritizes tasks, sets realistic deadlines, and uses time efficiently.

Nice To Haves

Master's Degree in psychology, social work, public health, or a related field with at least 2 year(s) of clinical research experience.
Experience working with children, adolscents and young people who have a mental health condition.
Fluent in Spanish.
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).

Responsibilities

Ensures compliance with study protocols and regulatory requirements.
Manages site performance and resolves issues.
Conducts participant interviews.
Ensures accurate and timely data entry into electronic data capture systems.
Reviews and resolves data queries.
Ensures 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.
Prepares and maintains regulatory documents.
Coordinates with ethics committees to safeguard participant rights.
Coordinates with clinical partners to identify eligible study participants.
Assists in screening, enrolling, and consenting of study participants.
Maintains communication with participants to ensure retention.
Addresses participant concerns and queries.
Prepares study reports and documentation.
Maintains accurate records of study activities.
Assists in the preparation of manuscripts and publications.
Conducts literature reviews to support study design and protocol development.
Assists in the training of new site staff and research team members.
Participates in internal and external audits.
Supports the development of study protocols and case report forms.
Attends conferences and workshops to stay updated on industry trends.
Adheres to internal controls and reporting structure.
Performs related duties as required.