Clinical Research Associate I

Job description

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 May 31, 2027 ---- Location: AUSTIN, TX ---- Job Details: General Notes This is a grant funded position with an end date of 12/31/2026, renewable based upon availability of funding, work performance, and progress toward research goals. The Clinical Research Associate I will manage and oversee day to day coordination and operations of assigned clinical research projects within the Psychiatry and Behavioral Sciences department. This role involves a significant focus on recruitment, enrollment and research activities for clinical research. 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. Responsibilities Site Management 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. Data Collection and Management 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. 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. Supports regulatory start-up activities and assists with IRB amendments under supervision. 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. Supports recruitment outreach and preliminary screenings under guidance of senior staff 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. Performs other tasks as assigned to support research team and project goals 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. Basic proficiency in Microsoft Office Suite (Word, Excel, Outlook). Familiarity with data entry platforms such as REDCap or ability and willingness to learn. Demonstrated ability to collaborate effectively with participants, clinical staff, and research teams. Detail-oriented with strong time management; able to follow protocols and maintain regulatory compliance. Required 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 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. Experience in research or healthcare environment (e.g., internships, volunteer roles, or academic projects). Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines. Licenses, Registrations or Certifications None Preferred: Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP). CITI Human Subjects Research Training. GCP (Good Clinical Practice) certification. Salary Range $40,000 + depending on qualifications Working Conditions May work around chemical fumes May work around standard office conditions May work around biohazards May work around chemicals Repetitive use of a keyboard at a workstation Use of manual dexterity Climbing of stairs Climbing of ladders Lifting and moving Occasional weekend, overtime and evening work to meet deadlines 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. ---- 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.