Senior Regulatory Analyst, IACUC

Utsw; United States; Presencial; USD 95.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PPO medical plan

Paid Time Off

Retirement Programs

Paid Parental Leave Benefit

Wellness programs

Tuition Reimbursement

PSLF Qualified Employer

Descripción de la vacante

UT Southwestern Medical Center in Dallas is seeking a Senior Regulatory Analyst to oversee the IACUC compliance program, manage the SAFI and PAM activities, and support related regulatory education for the research community.

The role requires strong project management, policy development, and coordination to ensure adherence to federal regulations, accreditation standards, and institutional requirements.

Formación

• Bachelor’s Degree in related field.
• 5 years of related research experience with Bachelor’s degree, or 3 years with Master’s.
• Master’s Degree strongly preferred.
• CPIA/CIP certification or extensive knowledge of regulations preferred.

Responsabilidades

• Provide expert-level knowledge of federal regulations and institutional policies.
• Review complex research documents for ethical and regulatory issues.
• Prepare, send and track incident notifications to researchers and officials as required.
• Develop, implement, and maintain policies, SOPs, and compliance processes.
• Lead projects to improve efficiency and strengthen compliance oversight.
• Maintain databases and tracking systems for regulatory monitoring and reports.

Conocimientos

Regulatory compliance

IACUC knowledge

Project management

Education and training

Educación

Bachelor’s Degree in related field

Master’s Degree preferred

Herramientas

SharePoint

Descripción del empleo

WHY UT SOUTHWESTERN?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you’ll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

In addition to the responsibilities outlined in the Senior Regulatory Analyst job description, the 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.

BENEFITS

UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education

Bachelor’s Degree in related field

• Experience

5 years of related research experience with Bachelor’s degree. or

3 years of related research experience with Master’s degree.

Preferred

• Education

Master’s Degree Advanced science degree strongly

• Experience

Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC) a plus.

• Licenses and Certifications

(CPIA) CERT PROF IN IACUC ADMINISTRTN or CIP or extensive current knowledge of regulations governing human or animal research protections strongly preferred.

JOB DUTIES

• 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 implements 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.

Desired Skills & Competencies

• Demonstrated experience coordinating or leading compliance oversight activities, including facility inspections, site visits, audits, or monitoring programs.
• Strong project management skills with the ability to independently lead multiple complex projects and priorities simultaneously.
• Experience developing, implementing, and maintaining policies, SOPs, compliance processes, and corrective action plans.
• Proven ability to analyze data, monitor trends, develop metrics, and maintain compliance tracking systems and databases.
• Excellent written and verbal communication skills.
• Strong presentation, training, and educational outreach skills.
• Ability to exercise sound judgment, critical thinking, and problem-solving in complex situations.
• Strong organizational skills with exceptional attention to detail and follow-through.
• Demonstrated ability to build collaborative relationships.
• Commitment to customer service, professionalism, confidentiality, and continuous process improvement.
• Proficiency with Microsoft Office applications, databases, and document management systems such as SharePoint.

SECURITY AND EEO STATEMENT

Security

This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.