Clinical Research Associate I

The University of Texas at Austin is a leading institution seeking a Clinical Research Associate I to manage and oversee clinical research projects within the Department of Psychiatry. The role focuses on planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols, with key responsibilities in site management, data collection, and participant recruitment.

Responsibilities

• Conducts site initiation, monitoring, and close-out visits
• Ensures compliance with study protocols and regulatory requirements
• Manages site performance and resolves issues
• Supports participant coordination and visit management, including scheduling, visit reminders, and reimbursement processes under PI or senior staff oversight
• Coordinates with clinical staff for specimen collection and protocol-required procedures
• Collects and verifies data from clinical sites
• Ensures accurate and timely data entry into electronic data capture systems
• Reviews and resolves data queries
• Assists with quality control and maintains study binders and source documentation in accordance with GCP and FDA regulations
• 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
• Supports regulatory start-up activities and assists with IRB amendments under supervision
• Evaluates medical records and performs screenings to identify eligible study participants
• Assists in screening and enrolling study participants
• Maintains communication with participants to ensure retention
• Addresses participant concerns and queries
• Supports recruitment outreach and preliminary screenings under guidance of senior staff
• 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
• Performs other tasks as assigned to support research team and project goals
• Adheres to internal controls and reporting structure
• Performs related duties as required

Preferred

• Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in clinical research experience
• Experience in research or healthcare environment (e.g., internships, volunteer roles, or academic projects)
• Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines
• Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)
• CITI Human Subjects Research Training
• GCP (Good Clinical Practice) certification
• Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in clinical research experience.
• Master's Degree in life sciences
• Research experience
• Healthcare environment experience
• Clinical Practice certification
• Certified Clinical Research Associate
• Certified Clinical Research Professional

Benefits

• Teacher Retirement System of Texas (TRS)

Company

• Public university offering higher education and research.
• Austin, Texas, USA
• http://www.texasenterprise.utexas.edu/
• Founded in 1883
• 10001+ employees

Qualifications

• Requires a Bachelor's Degree in life sciences, nursing, or a related field
• 1 year of relevant clinical research experience
• Relevant education and experience may be substituted as appropriate
• Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in clinical research experience
• Experience in research or healthcare environment (e.g., internships, volunteer roles, or academic projects)
• Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines
• Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)
• CITI Human Subjects Research Training
• GCP (Good Clinical Practice) certification
• 1 year of relevant clinical research experience.

Required skills

• Clinical research, Clinical trial monitoring, Data collection, Ethics committee coordination, Good Clinical Practice (GCP), Microsoft Office Suite, Participant recruitment, REDCap, Regulatory compliance, Report writing

Preferred skills

• Attention to detail, Communication, Team collaboration, Time management

Experience

• 1+ years