Job Posting Title:
Sr. Regulatory Clinical Research Coordinator
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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 Aug 31, 2026
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Location:
AUSTIN, TX
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Job Details:
Purpose
The Senior Regulatory Clinical Research Coordinator will manage and oversee regulatory aspects of clinical research projects within the Psychiatry and Behavioral Sciences department. This role involves a significant focus on regulatory work, compliance, internal monitoring activities, and ensuring FDA audit readiness. This position has an end date of 8/31/2026, but may be renewable based upon availability of funding, work performance, and progress toward goals.
Responsibilities
Regulatory Submissions
Compliance
Internal Monitoring
Conduct regular internal monitoring activities to ensure compliance with study protocols and regulatory requirements.
Provide training and support to research staff on regulatory requirements and best practices. Work closely with investigators, research staff, and regulatory bodies to facilitate project goals.
FDA Audit Readiness
QA/QC and Compliance
Understand the research life-cycle and manage all phases of clinical trials.
Develop and implement consenting language and processes, ensuring informed consent is obtained from all participants.
Prepare and submit Institutional Review Board (IRB) applications and amendments, and manage different types of IRB submissions.
Conduct screening and pre-screening activities to identify eligible study participants.
Conduct internal study audits ensuring adherence to study protocols.
Review medical charts and extract relevant data for research purposes.
Effectively communicate with Principal Investigators (PIs) and other clinicians to ensure smooth study operations.
Work both independently and as part of a team to achieve project goals.
Maintain detailed and accurate records of all research activities, including regulatory submissions and correspondence.
Ensure research program and projects are in full regulatory compliance
Required Qualifications
Bachelor's degree in a related field (e.g., Public Health, Psychology, Biology).
Minimum of 5 years of experience in clinical research and including regulatory experience with Institutional Review Board (IRB) processes and federal regulations governing human subject research.
Certified Clinical Research Coordinator (CCRC) or equivalent
Strong understanding of GCP, CFR, and ICH guidelines.
Excellent organizational and project management skills.
Proficiency in regulatory submission processes and documentation.
Strong communication and interpersonal skills.
Ability to work independently and as part of a team.
Attention to detail and strong problem-solving abilities.
Knowledge of the consenting process and IRB submission types.
Experience with patient screening, enrollment, and follow-up.
Experience with internal monitoring activities and FDA audit readiness.
Relevant education and experience may be substituted as appropriate.
Preferred Qualifications
Certified Clinical Research Professional (CCRP): Offered by the Society of Clinical Research Associates (SoCRA)
Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines.
Human Subjects Protection (HSP) Certification: Ensures knowledge of ethical guidelines in clinical research.
Salary Range
$62,400 + depending on qualifications
Working Conditions
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
Working with patients in clinical setting
Occasional weekend, overtime, and evening work to meet deadlines
This position will work remotely at the start of employment. The supervisor will work to identify the needs of the School and communicate the days and/or times expected to report on-site, up to 40 hours per week. The needs of the Dell Medical School will be reviewed on a regular basis, and ample notice will be provided of any changes. Remote work will require reliable internet access and a suitable workspace free from distractions.
Required Materials
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:
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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.
