JOB SUMMARY:

To provide administrative support and technical assistance for complying with federal and state requirements related to research projects and to assist in the preparation of institutional reports to appropriate federal and state regulating agencies and/or committees.    

MAJOR DUTIES / CRITICAL TASKS:

·        Promotes compliance with all current GLP requirements, including CFR 21 CFR 58, 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.

·        Maintains a current summary of training and experience and job description for individuals engaged in or supervising the conduct of a GLP study.

·        Assists the study directors and management with activities and procedures designed to promote compliance with current GLP regulations.

·        Drafts and maintains GLP procedures, policies and practices designed to promote compliance with regulatory requirements.

·        Assists with maintaining the master schedule sheet of all GLP studies conducted at UTMB indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor and name of the study director.

·        Maintains copies of all GLP study protocols.

·        Consults with faculty investigators and their staffs on the preparation of research protocol to assure compliance with federal regulations, including GLP requirements. 

·        Assists in the orientation of new researchers and staff to GLP requirements. 

·        Prepares meeting agendas, attends meetings and keeps the official minutes of all meetings. 

·        Maintains contact with academic, research, and administrative departments on matters of research and related training/educational programs. 

·        Evaluates on-going training needs and assists with the development of GLP training programs designed to promote compliance with regulatory requirements.

·        Adheres to internal controls established for department. 

·        Performs related duties as required.   

REQUIRED EDUCATION / EXPERIENCE:

Bachelor’s degree or equivalent and 4 years related experience.

Preferred: Good Laboratory Practice (GLP) training and/or certification, and research/clinical lab experience.

EQUIPMENT: 

Standard office equipment  

WORKING ENVIRONMENT: 

Standard office and 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 CHIEF HUMAN RESOURCES OFFICER.

 THE UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON IS AN EQUAL OPPORTUNITY / AFFIRMATIVE ACTION UNIVERSITY