Clinical Research Associate I

Job Posting Title :

Clinical Research Associate I

Hiring Department :

Department of Psychiatry

Position Open To : All Applicants

Weekly Scheduled Hours :

40

FLSA Status : Exempt

Earliest Start Date :

Immediately

Position Duration :

Expected to Continue Until Aug 31, 2026

Location : AUSTIN, TX

Job Details : General Notes

This is a grant funded position with an end date of 8 / 31 / 2026, renewable based upon availability of funding, work performance, and progress toward research goals.

Purpose

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.

ResponsibilitiesSite Management

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.

Data Collection and Management

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.

Regulatory Compliance

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.

Participate in internal and external audits and protocol reviews.

Participant Recruitment and Retention

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.

Reporting and Documentation

Prepares study reports and documentation.

Maintains accurate records of study activities.

Assists in the preparation of manuscripts and publications.

Marginal or Periodic Functions

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.

Knowledge / Skills / Abilities

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.

Required Qualifications

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).

Relevant education and experience may be substituted as appropriate

Preferred Qualifications

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.

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)

Salary Range

$40,000 + depending on qualifications

Working Conditions

May work around standard office conditions

Repetitive use of a keyboard at a workstation

Occasional weekend, overtime, and evening work to meet deadlines

Occasional interstate, intrastate, and international travel

This position is 100% on-campus, with an expectation to report to work on-site during the scheduled work week. Employees are expected to adhere to all applicable university health and safety protocols.

Required Materials

Resume / CV

3 work references with their contact information; at least one reference should be from a supervisor

Letter of interest

Important for applicants who are NOT current university employees or contingent workers : You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure thatALLRequired Materials have been uploaded. Once your job application has been submitted, you cannot make changes.

Important for Current university employees and contingent workers : As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questionspresented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.

Employment Eligibility :

Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion / transfer eligible may apply for positions without supervisor approval.

Retirement Plan Eligibility :

The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Background Checks :

A criminal history background check will be required for finalist(s) under consideration for this position.

Equal Opportunity Employer :

The University of Texas at Austin, as an equal opportunity / affirmative action employer,complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

Pay Transparency :

The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Employment Eligibility Verification :

If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.

E-Verify :

The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following :

• E-Verify Poster (English and Spanish) [PDF]
• Right to Work Poster (English) [PDF]
• Right to Work Poster (Spanish) [PDF]

Compliance :

Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.

The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.