Sr Research Support Specialist

Salary range: $65,600 – $80,000 per year. Final offer will reflect candidate’s relevant experience and qualifications.

Purpose of Position

Provides administrative and regulatory support for UT Arlington’s human subject research program.

Responsibilities

• Supports the Institutional Review Board (IRB) and Regulatory Services Director.
• Conducts pre-reviews and audits of research protocols for compliance with federal and state regulations, university policies, and IRB requirements.
• Assists with noncompliance investigations and reporting obligations.
• Coordinates reliance and reciprocity agreements for collaborative research.
• Educates researchers on FDA-regulated research and clinical trials.
• Maintains protocol and regulatory records.
• Supports campus-wide human subject protection training and outreach initiatives.

Essential Functions

• Conducts comprehensive reviews of human subject research protocols and study modifications to ensure compliance with federal regulations, university policies, IRB procedures, and ethical research standards.
• Classifies submissions, determines applicable regulatory requirements, provides compliance-related guidance and feedback to researchers, conducts exemption and minimal risk determinations, and advises the IRB on protocol review and compliance matters.
• Provides excellent customer service and consistent, accurate written and verbal guidance to students, faculty, and staff regarding human subject research requirements and the UTA IRB submission process; answers researcher questions and offers individualized assistance for specific research projects through in-person meetings, phone calls, webinars, and emails.
• Oversees central compliance activities for biomedical studies and clinical trials, including administration of ClinicalTrials.gov, SMART IRB, and ResearchMatch accounts; conducts Good Clinical Practice (GCP) audits and training; coordinates consultant reviews for clinical research studies; verifies FDA approval and clearance status for regulated drugs and devices; reviews grant applications for protocol congruency; and monitors researcher GCP training compliance.
• Maintains and tracks collaborative research studies involving external institutions; coordinates IRB reliance and reciprocity agreements with partner universities and healthcare systems; and ensures appropriate documentation and compliance for studies conducted under Single IRB arrangements.
• Advises and supports the Director in maintaining research compliance and integrity by contributing to program improvements, policy development, training, customer service, and research collaboration efforts. Assists with identifying and investigating protocol violations and noncompliance issues, communicates findings to leadership, and supports required reporting to federal agencies and sponsors in accordance with regulatory requirements.
• Conducts and coordinates day-to-day operations of the IRB program, including scheduling committee meetings, preparing regulatory-compliant meeting minutes, maintaining program records, monitoring protocol review deadlines, and preparing activity reports. Maintains current knowledge of best practices in human subject protection and research integrity to support program effectiveness and compliance.
• Supports campus-wide outreach and training initiatives by providing guidance on regulatory requirements, policies, and protocol preparation; developing educational materials and presentations; delivering researcher training; and assisting with the maintenance of standard operating procedures and website content.
• Coordinates with Regulatory Services functional areas, including animal research, biosafety, export control, conflict of interest, responsible conduct of research, and research misconduct. Collaborates with campus departments and external partners to address research-related compliance, financial, legal, and technology matters.
• Performs other duties as assigned.

Requirements

• Bachelor's degree in a related field and two (2) years of experience in clinical research ethics, compliance, or study coordination, OR six (6) years of an equivalent combination of education and experience.
• Experience interpreting federal regulations for the protection of human subjects in research and implementing programs or monitoring to meet regulatory requirements.

Preferred Qualifications

• Master's degree and three (3) years of experience in research ethics and compliance.
• Experience in research compliance in a higher education institution with a medical school or clinical program.
• Certified IRB Professional (CIP) or Certified Clinical Research Associate (CCRP).

Skills

• Knowledge of federal and state regulations and implementation of clinical research programs or monitoring to meet regulatory requirements.
• Thorough understanding of Good Clinical Practices (GCP) standards and requirements for FDA-regulated human subjects research.
• Extremely effective time management and organization skills for dealing with constant and recurring deadlines.
• High ethical standards and values.
• Excellent written and verbal communication skills.
• Ability to establish and maintain effective working relationships with researchers, administrators, and others.
• Knowledge of information systems and familiarity with database and word processing software.
• Highly motivated with strong initiative to improve, update, and develop programs to meet user expectations and changing regulatory requirements/guidelines.

Schedule

• Monday through Friday; 8:00 am – 5:00 pm.
• Remote work eligible. Periodic on-campus attendance may be required for mandatory meetings.

Working Conditions

• May work around standard office conditions.
• Repetitive use of a keyboard at a workstation.

Benefits

Position is benefits-eligible. The University of Texas at Arlington offers a comprehensive benefits package. Learn more about UTA benefits.