Regulatory Analyst Senior-IACUC;

In addition to the responsibilities outlined below, the Regulatory Analyst Senior position provides strategic oversight and operational leadership for the Institutional Animal Care and Use Committee (IACUC) compliance program, with primary responsibility for the management and execution of the Semiannual Facility Inspection (SAFI) program and support of Post-Approval Monitoring (PAM) activities. This position serves as a key resource to the research community, providing regulatory guidance, education, and training.

The Senior Regulatory Analyst exercises significant autonomy in planning, prioritizing, and leading complex compliance and oversight initiatives, including laboratory and facility site visits, SAFI and PAM activities, and the development, implementation, and maintenance of institutional policies, standard operating procedures (SOPs), and compliance processes. Serving as a subject matter expert on animal research regulations, accreditation standards, and institutional requirements. This role requires strong project management skills and is responsible for managing concurrent priorities, developing and maintaining databases and tracking systems that support compliance monitoring, inspections, corrective and preventive action plans, and program metrics.

The position prepares comprehensive reports and analyses for the IACUC and Institutional Official, manages follow-up activities through resolution, and leads projects designed to improve efficiency, strengthen compliance oversight, and enhance program effectiveness. The position demands excellent communication and interpersonal skills, sound judgment, adaptability, confidentiality, and strong customer service orientation.

• For campus-wide research, provide expert-level knowledge (application and interpretation) of federal regulations (DHHS, PHS, FDA, USDA, HIPAA, etc.), state regulations and policies, and institutional policies relevant to human or animal research and privacy. These include research related policies of UTSW.
• Review complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues.
• May approve protocol submissions eligible for expedited/designated member review.
• Document the decision-making process as required by federal regulations in applicable reviewer checklists, database and correspondence
• Provide guidance to research committee staff, board members/chairs and researchers on resolving complex and controversial issues
• Solve, recommend and implement solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the regulatory review process
• Directs, analyzes, coordinates, and evaluates research committee operation and procedures. Capture and document in the minutes controverted ethical and scientific issues identified during the review process. Summarize judgments/resolution of issues for each item of review
• Reads literature and attends training and other functions as necessary to keep current on changes to regulations and consider implications for institutional review processes
• Provide education and training to faculty and study staff, HRPP/IACUC Office staff and Board members related to the protocol review process and develop and distribute resource materials in an effort to improve protections for research subjects
• Responsible for preparing, sending and tracking incident notifications to researchers, institutional leadership and federal officials as required by federal regulations (i.e., FDA, USDA, HHS, PHS, DOD, DOE, etc.).
• Respond to follow-up inquires by federal agencies, faculty, and officials from affiliated institutions regarding notifications from the research committee.
• Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
• Establishes research committee goals and objectives and directs research committee evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
• Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
• Performs other duties as assigned.