JOB DESCRIPTION
The Research Integrity Compliance Officer-IRB and IACUC works in conjunction with the Director of the Office of Research Integrity (ORI) to ensure compliant, safe and ethical activities involving human subjects research and vertebrate animal research, teaching and testing across the University.
This position manages the Institutional Review Board (IRB) and Institutional Animal Care & Use Committee (IACUC) compliance programs.
RESPONSIBILITIES
Institutional Review Board (IRB) Administrator
- Advises and educates researchers regarding IRB policies, procedures and application development
- Conducts intake reviews of IRB protocol applications: reviews all protocols for consistency, completeness and compliance with federal, state, and local regulations & institutional policies; independently determines protocol review category (exempt, expedited or full-board); reviews informed consent documents to ensure presence of federally mandated elements; communicates action steps to researchers to facilitate IRB review
- Conducts independent reviews and approval determinations of all exempt protocols
- Manages protocol life cycle after intake: coordinates with IRB members to facilitate expedited protocol reviews and approvals; documents and communicates to researchers protocol determinations; routes modifications, continuing reviews, and closures for approval; coordinates post-approval monitoring of approved research.
- Develops and maintains the IRB forms, protocol archives, and compliance documentation
- Manages IRB meeting schedule and agenda; records IRB meeting minutes; assists ORI Director with IRB administration
- Develops and revises IRB policy and procedures in collaboration with ORI Director and IRB Chair regarding human subject research
- Facilitates the preparation and routing of reliance agreements and exempt site approvals for collaborative research with other institutions
- Supervises ORI Graduate Assistant
Institutional Animal Care & Use Committee (IACUC) Administrator
- Advises and educates faculty, staff and students regarding IACUC policies, procedures, and application development
- Conducts intake reviews of IACUC protocols; initiates action steps to principal investigators prior to committee review; routes protocols to committee members for review; documents and communicates to principal investigators protocol determination, annual reviews, modifications, and closure
- Develops and maintains the IACUC protocol tracking database: includes protocol intake, initial & annual reviews, modifications, personnel training records, and post-approval monitoring
- Coordinates post-approval monitoring of approved protocols
- Manages IACUC meeting schedule and agenda; records IACUC meeting minutes; develops and submits semi-annual and annual reports in accordance with USDA and OLAW requirements
- Develops and revises IACUC policy and procedures in collaboration with ORI Director and IACUC Chair regarding vertebrate animal activities
- Responsible for maintaining IACUC forms, protocol archives and compliance documentation
IACUC Animal Facilities Manager
- Manages Facilities Work Requests/Work Orders for IACUC and Animal Facilities
- IACUC contact for UTC Office of Environmental Health and Safety
- If needed, manages emergency situations with the Animal Facilities outside of regular business hours
- Ensures compliance with safety regulations and chemical hygiene guidelines, keep current safety data sheets for all substances in the Animal Facilities; Ensure compliance with hazardous and biohazardous waste management in the Animal Facilities
- Manages and maintains an up-to-date chemical inventory for all substances in the Animal Facilities
- Oversees annual Animal Facilities Space Inventory
- Oversees access for all faculty, staff, and students of the Animal Facilities
- Purchases supplies for Animal Facilities as needed
Additional Responsibilities
- Assists with mitigation of any research compliance concerns or issues involving human subjects research and vertebrate animal activities
- Prepares reports as necessary for the ORI Director and the Vice Chancellor for Research
- Stays up-to-date with federal, state, and UT policies pertaining to IRB and IACUC to ensure UTC’s policies and procedures are accurate and implemented promptly (via trainings, conferences, workshops, etc.)
- Participates in professional organizations (e.g. PRIM&R) and attends national conferences, workshops, and seminars to gain knowledge in the latest approaches for compliance within a university setting
- Maintains UTC IRB and IACUC websites and coordinates with Division webmaster to update as needed
- Assists ORI with policy and regulation education and training for UTC faculty, staff and students
- Assists with other research compliance activities as assigned (e.g. secondary coverage for Institutional Biosafety Committee functions)
Knowledge, Skills, and Abilities
- In-depth knowledge of federal and state regulations pertaining to human subjects’ research and vertebrate animal research, teaching and testing (e.g. 45 CFR 46; Belmont Report; HIPAA Privacy Rule; PHS Policy on the Care and Use of Laboratory Animals; The Guide for the Care and Use of Laboratory Animals, Animal Welfare Act, etc.)
- Knowledge of research administration and compliance principles, procedures, and terminology applicable in academia
- Strong knowledge of research methodology
- Knowledge of best practices for chemical hygiene and chemical/biohazard storage and disposal
- Ability to learn, use and train end users on protocol submission platforms (e.g. Huron Research Suite)
- Ability to review and process complex information and adapt to an evolving regulatory environment
- Ability to make independent judgments, problem-solve, meet deadlines, and manage compliance programs with minimal supervision
- Computer skills, including word processing, database development and management
- Strong organizational skills and attention to detail; Strong critical thinking and communication skills
- Skill in collaborating, building and maintaining relationships with faculty, staff and students across multiple disciplines
- Skilled in reviewing, interpreting and providing guidance to others regarding ethical frameworks and federal regulations