Senior Regulatory Analyst, Human Research Protection IRB

UT Southwestern Medical Center; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

UT Southwestern Medical Center in Dallas seeks a detail-oriented research regulatory specialist to work with investigators and research personnel on developing and refining proposals for human clinical trials and animal studies.

You will perform protocol pre-review, advise on regulatory issues to improve IRB and IACUC approvals, and provide training on federal and institutional requirements across DHHS, FDA, HIPAA, and related policies.

Qualifications

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

Responsibilities

• Provide expert-level knowledge of federal regulations (DHHS, PHS, FDA, USDA, HIPAA) and institutional policies relevant to human/animal research.
• Review complex scientific documents to identify ethical and regulatory issues.
• Guide research committee staff and investigators on protocol submissions and regulatory review processes.
• Document decision-making processes in required checklists, databases, and correspondence.
• Educate faculty and staff on protocol review processes and distribute resource materials to improve protections for human/animal subjects.
• Develop and maintain relationships with internal/external departments and agencies involved in the research program.

Skills

Regulatory knowledge

Research coordination

Federal regulations

Regulatory training

Education

Bachelor's Degree in related field

Master's Degree in related science

Job description

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

The purpose of this job is to work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials or animal research. For campus-wide research, perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB/IACUC approvals.

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, a