Research Regulatory Specialist, Institute for Translational Science (Hybrid)

UTMB Health•Galveston, TX

2d•Hybrid

About The Position

The Research Regulatory Specialist provides regulatory expertise to faculty members, principal investigators, and research personnel to help ensure clinical processes comply with good clinical practice (GCP), IRB policies and procedures, sponsor requirements, and UTMB policies and guidelines. The position identifies and escalates protocol deviations, noncompliance, and data discrepancies to support adherence to study protocols and applicable regulatory frameworks. Under the direction of the Director of Research Integrity and Regulatory Affairs, the specialist performs and manages an assigned portfolio, assists with regulatory policy development and maintenance, and supports timely service to customers. The role provides analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs. It supports regulatory compliance activities including IRB processing and approval, IND/IDE submissions and management, and ClinicalTrials.gov listing and reporting. The specialist analyzes study processes, troubleshoots clinical trials, maintains quality-system or training databases, prepares reports, supports improvement programs, and contributes to policies, procedures, training, and regulatory submissions. The position works across research and administrative units, academic schools and departments, UTMB administration, the University of Texas System, government agencies, and accrediting organizations. The position is based in a standard office environment at UTMB’s main campus or other study locations. The work arrangement is hybrid. Salary is commensurate with experience.

Requirements

Bachelor’s degree or equivalent.
Five years of related experience.
Understanding of research regulatory requirements, including GCP.
Applied understanding of applicable regulations, such as Good Clinical Practice, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws.
Ability to understand technical, scientific, and medical information.
High attention to detail and accuracy.
Ability to maintain composure in difficult circumstances and adapt to shifting priorities and competing demands.
Ability to foster collaborative, constructive relationships with colleagues, faculty, and university management.
Ability to work effectively as a team player in a complex, matrix organization.
Exceptional organizational skills and a results focus that supports timely progress on execution priorities.
Competencies in cross-functional relationships, decision-making, execution/results/process improvement, and customer satisfaction.

Nice To Haves

Two years of clinical monitoring experience or three years of experience developing training programs.
Clinical Research Associate (CRA) certification.
Ability to understand and apply knowledge of clinical trial designs to trial execution.
Experience in the medical or healthcare industry.

Responsibilities

Provide analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs.
Support regulatory compliance activities, including IRB processing and approval, IND/IDE submission and management, and ClinicalTrials.gov listing and reporting.
Advise on compliance with GCP, the Code of Federal Regulations, and other pertinent clinical research regulations.
Analyze study processes to identify opportunities to improve compliance, efficiency, and effectiveness, and troubleshoot clinical trials and related activities.
Manage and maintain quality-system and/or training databases.
Prepare or assist with annual reports and quality trending reports, and report quality levels of staff, systems, and production activities.
Preside over improvement programs and evaluate quality events, incidents, queries, and complaints.
Develop and implement standard operating procedures and institutional policies and procedures.
Monitor regulatory changes and remain current on quality standards, legislation, and compliance issues.
Compile and prepare materials for submission to regulatory agencies and communicate regulatory rules through corporate policies and procedures.
Create training and education programs when needed and work with faculty and staff to develop relevant education programs.
Ensure investigator, vendor, facility, and system audits are conducted, and communicate critical compliance risks to senior management.
Lead preparation for, conduct of, and responses to regulatory agency activities.
Adhere to internal controls and reporting structure and perform related duties as required.