JOB SUMMARY:

To provide strategic, managerial, technical and educational support and expert advice regarding compliance with federal and state requirements related to pre-clinical research projects; to provide oversight for Good Laboratory Practice compliance, to manage the preparation of institutional reports to UTMB executive and operational management officials, and to appropriate federal and state regulating agencies and/or committees.    

ESSENTIAL JOB FUNCTIONS:

• Ensures/Manages compliance with all current Good Laboratory Practice (GLP) and other relevant regulatory requirements (21 CFR Part 58 and equivalent international guidelines and regulations), UTMB IACUC and ARC policies, procedures, state and federal regulations in coordination with UTMB’s Quality Assurance Unit, Institutional Animal Care and Use Committee, and Animal Resource Center.

• Provides strategic vision for activities and procedures designed to promote compliance with current GLP regulations.

• Serves as primary liaison for academic, research, and administrative departments on matters of research and related training/educational programs to provide strategic vision regarding the implementation of regulated studies. 

• Analyzes business and industry trends in regulatory compliance.

• Provides specialist advice to senior GLP and other UTMB management for business and strategic planning as it pertains to regulated studies.

• Provides expert guidance in the development and oversight of GLP study protocols and other required documentation.

• Develops implements and maintains administrative procedures, policies and practices designed to promote compliance with GLP and other regulatory requirements.

• Advises management, investigators, study directors and staff regarding the development of laboratory, and study-specific policies and procedures compliant with relevant regulations.

• Works closely with faculty investigators and their staffs to prepare research study protocols and required reports to sponsors or regulatory agencies and assures compliance of reports with sponsor, state and federal requirements/regulations, including GLP regulations. 

• Evaluates on-going training needs, and develops and oversees implementation of education materials/programs to facilitate orientation and continuing education of researchers and staff related to GLP regulations. 

• Develops budgets for compliant studies and/or provides specialist advice to senior investigators regarding budgets and business planning for regulated studies.

• Adheres to internal controls established for department. 

MARGINAL OR PERIODIC JOB FUNCTIONS:

·        Performs related duties as required

REQUIRED EDUCATION / EXPERIENCE:

Bachelor’s degree, or equivalent, in science, engineering, information technology, business administration, accounting, finance, or other related discipline; and 7 years related experience in management or quality assurance oversight of GLP or other regulated research activities. 

Good Laboratory Practice (GLP) training and/or certification (e.g. Registered Quality Assurance Professional in GLP).

EQUIPMENT:

Standard office equipment.

WORKING ENVIRONMENT/LOCATION OF POSITION:

Standard Office and biocontainment laboratory environments.

OTHER:

Specific job requirements or physical location of some positions allocated to this classification, may render this position security sensitive, and thereby subject to the provisions of Section 51.215, Texas Education Code.

ANY QUALIFICATIONS TO BE CONSIDERED AS EQUIVALENTS IN LIEU OF STATED MINIMUMS REQUIRE THE PRIOR APPROVAL OF THE VICE PRESIDENT OF HUMAN RESOURCES AND EMPLOYEE SERVICES.