Research Regulatory Specialist, Institute for Translational Science (Hybrid)

University of Texas Medical Branch (UTMB)•Galveston, TX

9h•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 role 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 helps deliver timely service to customers. The position provides analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs and supports regulatory compliance activities, including IRB processing and approval, IND/IDE submission and management, and ClinicalTrials.gov listing and reporting. It analyzes study processes, troubleshoots clinical trials, maintains quality and training databases, prepares quality reports, supports improvement programs, and helps develop institutional policies and procedures. The specialist monitors regulatory changes, supports regulatory submissions and audits, communicates critical compliance risks to senior management, and may develop training and education programs. The position interacts with units across Research Regulations and Compliance, Research Administration, schools and departments, central UTMB administration, the University of Texas System, state and federal agencies, and accrediting organizations. It works in a standard office environment at UTMB’s main campus or other study locations. Salary is commensurate with experience.

Requirements

Bachelor’s degree or equivalent.
At least 5 years of related experience.
Understanding of research regulatory requirements, including GCP.
Applied understanding of applicable regulations, such as GCP, FDA Code of Federal Regulations, clinical research ethics, HIPAA, and patient privacy laws.
Ability to understand technical, scientific, and medical information.
Demonstrated ability to maintain composure in difficult circumstances and adapt to shifting priorities and competing demands.
High attention to detail and accuracy.
Ability to foster collaborative and 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-focused approach to timely execution priorities.

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 clinical trial design knowledge 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.
Serve as a regulatory expert on GCP, the Code of Federal Regulations, and other pertinent clinical research regulations.
Analyze study processes to identify opportunities to improve compliance, efficiency, and effectiveness.
Troubleshoot clinical trials and related activities.
Manage and maintain quality-system and/or training databases.
Prepare annual reports and quality-trending reports, and report quality levels of staff, systems, and production activities.
Lead or 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.
Communicate regulatory requirements through corporate policies and procedures.
Create training and education programs as needed and collaborate with faculty and staff on relevant education programs.
Ensure investigator, vendor, facility, and system audits are conducted.
Communicate critical compliance risks identified through audits and other activities to senior management.
Lead preparation for and conduct of regulatory agency interactions and responses.
Adhere to internal controls and reporting structure and perform related duties as required.