Clinical Research Associate I

University of Texas at Austin • Austin, TX

79d • $40,000

About The Position

The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data. The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, the University of Texas at Austin and regulating agency policies. A successful candidate will possess all of the following knowledge, skill and abilities: attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; the ability to multi-task in a fast-paced environment while working with a diverse subject population; ability to work well independently, ability to complete projects in a timely manner, and ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines; excellent organizational skills; and excellent interpersonal skills to work effectively in a team.

Requirements

• Requires a Bachelor's Degree in life sciences, nursing, or a related field.
• 1 year of relevant clinical research experience.
• Familiarity with IRB processes and human subjects protection standards.
• Experience with electronic data capture systems (e.g., REDCap).

Nice To Haves

• Master's Degree in life sciences, nursing, or a related field.
• At least 2 years of experience in Clinical research experience preferably 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).

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.
• Manages site performance and resolves issues.
• Administers questionnaires, collect medical history, and perform study procedures.
• Maintains rapport with participants to ensure retention and address concerns.
• Obtains informed consent and ensure participant safety throughout protocol procedures.
• Coordinates with affiliated departments and external collaborators.
• Collects and verifies data from clinical sites.
• Ensures accurate and timely data entry into electronic data capture systems (e.g. REDCap).
• Reviews and resolves data queries.
• Assists with manuscript and grant preparation, including opportunities for authorship.
• Maintains and updates study databases and data collection forms.
• Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Facilitates institutional review board (IRB) applications, submissions, and updates across multiple sites.
• Prepares and maintains regulatory documents.
• Coordinates with ethics committees to safeguard participant rights.
• Participates in internal and external audits and protocol reviews.
• 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.
• 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.

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• paid_holidays
• paid_volunteer_time
• tuition_reimbursement
• professional_development

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees