Senior Regulatory Analyst, Human Research Protection IRB

%3Cb%3EWHY UT SOUTHWESTERN?%3C/b%3E%3Cbr%3E%0AWith 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

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for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to %3Ca href=%22https%5C://www.utsouthwestern.edu/newsroom/articles/year-2022/july-us-news-best-hospital.html%22 target=%22_blank%22%3EU.S. News %26 World Report%3C/a%3E, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive

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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%27ll discover a culture of teamwork, professionalism, and a rewarding career!%0A%0A%3Cbr%3E%3Cbr%3E%3Cb%3EJOB SUMMARY%3C/b%3E%3Cbr%3E%0AThe 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. %0A %3Cbr%3E%3Cbr%3E%3Cp%3E%3Cb%3EBENEFITS%3C/b%3E%3Cbr%3E%0AUT Southwestern is proud to offer a competitive and comprehensive

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package to eligible employees. Our

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are designed to support your overall wellbeing, and include%5C:%3C/p%3E%0A%3Cul%3E%0A %3Cli%3EPPO medical plan, available day one at no cost for full-time employee-only coverage%3C/li%3E%0A %3Cli%3E100% coverage for preventive healthcare-no copay%3C/li%3E%0A %3Cli%3EPaid Time Off, available day one%3C/li%3E%0A %3Cli%3ERetirement Programs through the Teacher Retirement System of Texas (TRS)%3C/li%3E%0A %3Cli%3EPaid Parental Leave Benefit%3C/li%3E%0A %3Cli%3EWellness programs%3C/li%3E%0A %3Cli%3ETuition Reimbursement%3C/li%3E%0A %3Cli%3EPublic Service Loan Forgiveness (PSLF) Qualified Employer%3C/li%3E%0A %3Cli%3E%3Ca href=%22http%5C://jobs.utsouthwestern.edu/

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/#top%22 target=%22_blank%22%3ELearn more about these and other UTSW employee

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!%3C/a%3E%0A %3C/li%3E%0A%3C/ul%3E%3Cbr%3E%3Cbr%3E%3Cb%3E%3Cb%3EEXPERIENCE AND EDUCATION%3C/b%3E%3C/b%3E%3Cbr%3E%0A%3Cbr%3E%3Cb%3ERequired%3C/b%3E%3Cul%3E%3Cb%3E%3Cli%3EEducation%3C/b%3E%3Cbr%3EBachelor%27s Degree in related field %3Cbr%3E%3C/ul%3E%3Cul%3E%3Cb%3E%3Cli%3EExperience%3C/b%3E%3Cbr%3E5 years of related research experience with Bachelor%27s degree. or %3Cbr%3E%0A3 years of related research experience with Master%27s degree. %3Cbr%3E%3C/ul%3E%3Cb%3EPreferred%3C/b%3E%3Cul%3E%3Cb%3E%3Cli%3EEducation%3C/b%3E%3Cbr%3EMaster%27s Degree Advanced science degree strongly %3Cbr%3E%3C/ul%3E%3Cul%3E%3Cb%3E%3Cli%3EExperience%3C/b%3E%3Cbr%3E Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC) a plus. %3Cbr%3E%3C/ul%3E%3Cul%3E%3Cb%3E%3Cli%3ELicenses and Certifications%3C/b%3E%3Cbr%3E(CPIA) CERT PROF IN IACUC ADMINISTRTN or CIP or extensive current knowledge of regulations governing human or animal research protections strongly preferred. %3Cbr%3E%3C/ul%3E%3Cbr%3E%3Cb%3E%3Cb%3EJOB DUTIES%3C/b%3E%3C/b%3E%3Cul%3E %3Cli%3EFor 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. %3C/li%3E%0A%3Cli%3EReview complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues. %3C/li%3E%0A%3Cli%3EMay approve protocol submissions eligible for expedited/designated member review. %3C/li%3E%0A%3Cli%3EDocument the decision making process as required by federal regulations in applicable reviewer checklists, database and correspondence %3C/li%3E%0A%3Cli%3EProvide guidance to research committee staff, board members/chairs and researchers on resolving complex and controversial issues %3C/li%3E%0A%3Cli%3ESolve, recommend and implements solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the regulatory review process %3C/li%3E%0A%3Cli%3EDirects, 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 %3C/li%3E%0A%3Cli%3EReads literature and attends training and other functions as necessary to keep current on changes to regulations and consider implications for institutional review processes %3C/li%3E%0A%3Cli%3EProvide 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 %3C/li%3E%0A%3Cli%3EResponsible 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.). %3C/li%3E%0A%3Cli%3ERespond to follow-up inquires by federal agencies, faculty, and officials from affiliated institutions regarding notifications from the research committee. %3C/li%3E%0A%3Cli%3EDevelops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program. %3C/li%3E%0A%3Cli%3EEstablishes 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. %3C/li%3E%0A%3Cli%3EResponsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient. %3C/li%3E%0A%3Cli%3EPerforms other duties as assigned. %3C/li%3E %0A%3Cbr%3E%3C/ul%3E%3Cb%3E%3Cb%3ESECURITY AND EEO STATEMENT%3C/b%3E%3C/b%3E%3Cbr%3E%3Cbr%3E%3Cb%3ESecurity%3C/b%3E%3Cbr%3EThis position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.%3Cbr%3E%3Cbr%3E%3Cb%3EEEO%3C/b%3E%3Cbr%3E%0AUT 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.%3C/br%3E