Clinical Research Associate I

Job Posting Title:

Clinical Research Associate I

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Hiring Department:

Department of Psychiatry

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Position Open To:

All Applicants

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Weekly Scheduled Hours:

40

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FLSA Status:

Exempt

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Earliest Start Date:

Immediately

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Position Duration:

Expected to Continue Until Sep 01, 2027

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Location:

AUSTIN, TX

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Job Details:

General Notes

This is a grant-funded position with an end date of September 1, 2027, 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). This role may coordinate the data collection and operations of multiple concurrent clinical research studies under the guidelines of research protocols, The University of Texas at Austin, and regulatory agency policies.

A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.

Responsibilities

Site Management & Study Execution

• 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.

• Ensure compliance with study protocols and regulatory requirements.

• Manage site performance and resolve issues.

• Administer questionnaires, collect medical history, and perform study procedures.

• Maintain rapport with participants to support retention and address concerns.

• Obtain informed consent and ensure participant safety throughout protocol procedures.

• Coordinate with affiliated departments and external collaborators.

Data Collection & Management

• Collect and verify data from clinical sites.

• Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).

• Review and resolve data queries.

• Assist with manuscript and grant preparation, including opportunities for authorship.

• Maintain and update study databases and data collection forms.

Regulatory Compliance & Oversight

• Ensure 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.

• Prepare and maintain regulatory documents.

• Coordinate with ethics committees to safeguard participant rights.

• Participate in internal and external audits and protocol reviews.

Participant Recruitment & Retention

• Evaluate medical records and perform screenings to identify eligible study participants.

• Assist in screening and enrolling study participants.

• Maintain communication with participants to support retention.

• Address participant concerns and inquiries.

Reporting & Documentation

• Prepare study reports and documentation.

• Maintain accurate records of study activities.

• Assist in the preparation of manuscripts and publications.

Marginal or Periodic Functions

• Conduct literature reviews to support study design and protocol development.

• Assist in training new site staff and research team members.

• Participate in internal and external audits.

• Support development of study protocols and case report forms.

• Attend conferences and workshops to stay updated on industry trends.

• Adhere to internal controls and reporting structure.

• Perform related duties as required.

Knowledge, Skills, and Abilities

• Maintain organized records, follow detailed procedures, and double-check work for accuracy.

• Write clear and concise reports, actively listen, and present information effectively.

• Analyze information, develop solutions, and implement corrective actions.

• Collaborate with team members and support team decisions.

• Prioritize tasks, set realistic deadlines, and manage time effectively.

Required Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field

• One 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 two years of clinical research experience, preferably involving pediatric or neurodevelopmental populations

• Experience with statistical software (e.g., R, SAS, SPSS)

• 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)

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 will be assigned on-campus with an expectation to report to work on-site during the scheduled work week.

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 that ALL Required 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 questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.

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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.

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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.

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Background Checks:

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

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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.

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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.

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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.

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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]

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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.