IRB Compliance Analyst

Job Summary:

The IRB Compliance Analyst provides administrative and regulatory support for the Human Research Protection Program (HRPP) and Institutional Review Board (IRB). The position assists with intake, pre-review, coordination, tracking, and processing of human subjects research submissions in Cayuse Human Ethics, including initial studies, modifications, continuing reviews, renewals, closures, reliance-related activities, and reportable events/incidents. The analyst supports investigators and research staff by facilitating compliance with institutional policies and applicable human subjects research regulations under the direction of the Director of Research Compliance. Complex, novel, or high-risk regulatory matters are referred to the Director of Research Compliance for review and determination. This is a temporary, hourly position approved for limited-capacity support and is capped at an average of 29 hours per week.

Duties & Essential Job Functions:

1. Conducts administrative and regulatory pre-review of assigned human subjects research submissions in Cayuse Human Ethics, including initial applications, modifications, continuing reviews, renewals, closures, personnel updates, reliance-related submissions, and reportable events/incidents.
2. Reviews study materials for completeness, consistency, required documentation, consent language, recruitment materials, investigator training, and other submission requirements prior to IRB review.
3. Applies established HRPP/IRB procedures, institutional guidance, and applicable human subjects research requirements to identify administrative and regulatory issues requiring investigator revision or supervisory escalation.
4. Communicates with investigators, faculty, students, and research staff regarding submission deficiencies, required revisions, study status updates, and administrative follow-up requirements.
5. Prepares and maintains IRB correspondence, review records, meeting materials, determinations, tracking logs, and electronic study files.
6. Assists with processing exempt, expedited, and board-review submissions under established office procedures and delegated authority.
7. Maintains study tracking systems and assists with protocol status updates, approval dates, expiration monitoring, renewal reminders, and investigator communications.
8. Provides administrative support for IRB meetings, including agenda preparation, document distribution, reviewer assignments, minutes support, and follow-up communications.
9. Assists with reliance-related documentation, institutional authorizations, external IRB coordination activities, and related communications as assigned.
10. Supports investigators in navigating Cayuse Human Ethics and institutional submission requirements.
11. Assists with data entry, records management, workload tracking, metrics reporting, and other administrative activities supporting HRPP/IRB operations.
12. Maintains confidentiality and safeguards protected research information and institutional records in approved systems and storage locations.
13. Performs other IRB- and HRPP-related administrative duties as assigned by the Director of Research Compliance.

Required Education & Experience:

• Bachelor's degree in a related field.
• Experience working in a higher education, healthcare, research, regulatory compliance, or administrative environment.
• Experience reviewing, processing, coordinating, or managing documentation requiring attention to detail and adherence to established procedures.

Preferred Education & Experience:

• Experience supporting Institutional Review Board (IRB) operations.
• Experience working with human subjects research submissions, regulatory documents, consent forms, or compliance-related processes.
• Experience using electronic research administration systems, such as Cayuse, IRBNet, eIRB, or similar platforms.
• Experience in higher education research administration.

Required Licensure/Certification/Specialized Training:

• None.

Preferred Licensure, Certification, and/or Specialized Training:

• Completion of CITI Human Subjects Research training.
• Certified IRB Professional (CIP) credential or ability to obtain.

Knowledge, Skills & Abilities:

• Knowledge of human subjects research protections and the Common Rule preferred.
• Knowledge of IRB processes, protocol review workflows, informed consent requirements, and research compliance principles preferred.
• Ability to review documents for completeness, accuracy, consistency, and compliance with established requirements.
• Strong written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to manage multiple submissions and competing deadlines.
• Ability to maintain confidential records and sensitive information.
• Proficiency in Microsoft Office applications and database systems.
• Ability to work independently while recognizing when issues require escalation to supervisory staff.

TCU Core Competencies:

University Core Competencies definitions may be found on the Human Resources website and in the staff performance management system.

Physical Requirements (With or Without Accommodations):

• Visual acuity to read information from computer screens, forms and other printed materials and information.
• Able to speak (enunciate) clearly in conversation and general communication.
• Hearing ability for verbal communication/conversation/responses via telephone, telephone systems, and face-to-face interactions.
• Manual dexterity for typing, writing, standing and reaching, flexibility, body movement for bending, crouching, walking, kneeling and prolonged sitting.
• Lifting and moving objects and equipment up to 10 lbs.

Work Environment:

• Work is indoors and sedentary and is subject to schedule changes and/or variable work hours.
• This role is an on campus, in-person position.
• There are no harmful environmental conditions present for this job.
• The noise level in this work environment is usually moderate.

Employment Values Statement:

Texas Christian University values Integrity, Engagement, Community, and Excellence in the workplace. TCU treats applicants and employees with fairness and respect. TCU hires and promotes individuals based on their qualifications and their commitment to making a positive impact on our student-centered community. TCU is an equal opportunity employer and follows all applicable employment laws. TCU fairly considers all qualified individuals, ensuring we are a workplace free from unlawful discrimination and harassment.