Sr Research Support Specialist

The University of Texas at Arlington; Arlington (TX); Hybrid; USD 65,600 - 80,000; Full time

Benefits offered by this job

Benefits eligible

Remote work eligibility

Job summary

The University of Texas at Arlington seeks a Regulatory Compliance Specialist to support UT Arlington’s human subject research program. You will assist with IRB operations, regulatory reviews, and documentation to ensure compliance with federal and state rules.

You will coordinate reliance agreements, conduct audits, train researchers, and maintain records across campus, collaborating with Regulatory Services and external partners.

Qualifications

• 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 to include the interpretation of federal regulations for the protection of human subjects in research and implementation of programs or monitoring to meet regulatory requirements.

Responsibilities

• Reviews human subject research protocols for compliance with federal regulations and IRB procedures.
• Provides guidance on regulatory requirements and determines exemption/minimal risk determinations.
• Maintains regulatory records, supports training, and assists with campus outreach on compliance.
• Coordinates IRB reliance and reciprocity agreements with partners and oversees related accounts and audits.
• Assists with reporting to federal agencies and sponsors and monitors training compliance.

Skills

Regulatory compliance

IRB knowledge

GCP knowledge

Communication skills

Education

Bachelor's degree in related field

Master's degree (preferred)

Tools

ClinicalTrials.gov

SMART IRB

ResearchMatch

Job description

Salary

The annual salary for this position ranges from $65,600 to $80,000. The final offer will be commensurate with the candidate’s relevant experience and qualifications.

Documents Needed to Apply

Required

• Resume
• Cover letter

Purpose of Position

Provides administrative and regulatory support for UT Arlington’s human subject research program. Responsibilities include supporting the Institutional Review Board (IRB) and Regulatory Services Director; conducting pre-reviews and audits of research protocols for compliance with federal and state regulations, university policies, and IRB requirements; assisting with noncompliance investigations and reporting obligations; coordinating reliance and reciprocity agreements for collaborative research; educating researchers on FDA-regulated research and clinical trials; maintaining protocol and regulatory records; and supporting 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.

Required Qualifications

• 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 to include the interpretation of federal regulations for the protection of human subjects in research and implementation of programs or monitoring to meet regulatory requirements.

Preferred Qualifications

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

Knowledge, Skills & Abilities

• 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.

Work Schedule

• Monday through Friday; 8:00am through 5:00pm
• Remote work eligibility.
• 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 Information

Position is benefit eligible:

Yes

https://www.uta.edu/hr/employee-benefits

PreEmployment Background Check

It is the policy of The University of Texas at Arlington to conduct a pre employment background check on any applicant who is under final consideration for employment with the University.

This position may have access to critical infrastructure as defined by Section 113.001(2) of the Texas Business and Commerce Code. If so, to be hired for and continue to be employed in this position you must maintain the security or integrity of the infrastructure as set forth in Texas Executive Order GA 48. By assuming this position, and if you have access to critical infrastructure, you authorize the University to conduct routine background checks.

University Information

The University of Texas at Arlington (UTA) is located in the heart of the Dallas-Fort Worth-Arlington metroplex, a vibrant and diverse metropolitan area that is home to over 7 million people, one of the fastest-growing tech economies in the United States, and a wide array of arts, entertainment, and cultural activities. As a comprehensive teaching, research, and public service institution, UTA is dedicated to the advancement of knowledge through scholarship and creative work. With an enrollment of more than 42,000 students, UTA is the second largest in the University of Texas System. As a result of its combination of rigorous academics and innovative research, UTA is designated as a Carnegie R-