%3Ch2%3ESenior Regulatory Associate - Cardiovascular %26amp; Thoracic Surgery Department%3C/h2%3E%3Cp%3E%3Cstrong%3EWHY UT SOUTHWESTERN?%3C/strong%3E%3Cbr%3EWith 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 %3Ca target=%22_blank%22 rel=%22noopener noreferrer%22 href=%22https://www.utsouthwestern.edu/newsroom/articles/year-2022/july-us-news-best-hospital.html%22%3EU.S. News %26amp; 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 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%27ll discover a culture of teamwork, professionalism, and a rewarding career!%26nbsp;%3Cbr%3E%3Cbr%3E%3Cstrong%3EJOB SUMMARY%3C/strong%3E%3Cbr%3EThe purpose of this job is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. 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 or IACUC approvals.%26nbsp;%3Cbr%3E%3Cbr%3E%26nbsp;%3C/p%3E%3Cp%3E%3Cstrong%3EBENEFITS%3C/strong%3E%3Cbr%3EUT 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:%3C/p%3E%3Cul%3E%3Cli%3EPPO medical plan, available day one at no cost for full-time employee-only coverage%3C/li%3E%3Cli%3E100% coverage for preventive healthcare-no copay%3C/li%3E%3Cli%3EPaid Time Off, available day one%3C/li%3E%3Cli%3ERetirement Programs through the Teacher Retirement System of Texas (TRS)%3C/li%3E%3Cli%3EPaid Parental Leave Benefit%3C/li%3E%3Cli%3EWellness programs%3C/li%3E%3Cli%3ETuition Reimbursement%3C/li%3E%3Cli%3EPublic Service Loan Forgiveness (PSLF) Qualified Employer%3C/li%3E%3Cli%3E%3Ca target=%22_blank%22 rel=%22noopener noreferrer%22 href=%22http://jobs.utsouthwestern.edu/benefits/#top%22%3ELearn more about these and other UTSW employee benefits!%3C/a%3E%3C/li%3E%3C/ul%3E%3Cp%3E%3Cbr%3E%3Cbr%3E%3Cstrong%3EEXPERIENCE AND EDUCATION%3C/strong%3E%3Cbr%3E%3Cbr%3E%3Cstrong%3ERequired%3C/strong%3E%3C/p%3E%3Cul%3E%3Cli%3E%3Cstrong%3EEducation%3C/strong%3E%3Cbr%3EBachelor%27s Degree%26nbsp;%3Cbr%3E%26nbsp;%3C/li%3E%3C/ul%3E%3Cul%3E%3Cli%3E%3Cstrong%3EExperience%3C/strong%3E%3Cbr%3E3 years of related experience in review, oversight, or performance management of scientific research projects.%26nbsp;%3Cbr%3EMay consider experience and education in lieu of requirements%26nbsp;%3Cbr%3E%26nbsp;%3C/li%3E%3C/ul%3E%3Cp%3E%3Cstrong%3EPreferred%3C/strong%3E%3C/p%3E%3Cul%3E%3Cli%3E%3Cstrong%3EEducation%3C/strong%3E%3Cbr%3EAdvanced degree in health sciences field%26nbsp;%3Cbr%3E%26nbsp;%3C/li%3E%3C/ul%3E%3Cul%3E%3Cli%3E%3Cstrong%3EExperience%3C/strong%3E%3Cbr%3EPrevious service on an IRB or IACUC a plus.%26nbsp;%3Cbr%3E%26nbsp;%3C/li%3E%3C/ul%3E%3Cul%3E%3Cli%3E%3Cstrong%3ELicenses and Certifications%3C/strong%3E%3Cbr%3ECERTIFIED PROFESSIONAL or%3Cbr%3EPrevious service on an IRB%26nbsp;%3Cbr%3E%26nbsp;%3C/li%3E%3C/ul%3E%3Cp%3E%3Cbr%3E%3Cstrong%3EJOB DUTIES%3C/strong%3E%3C/p%3E%3Cul%3E%3Cli%3ECollaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.%3C/li%3E%3Cli%3EPrepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.%3C/li%3E%3Cli%3EMaintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.%3C/li%3E%3Cli%3EMonitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.%3C/li%3E%3Cli%3ERecommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures.%3C/li%3E%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%3Cli%3EReads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research.%3C/li%3E%3Cli%3EPerforms other duties as assigned.%3C/li%3E%3C/ul%3E%3Cp%3E%3Cstrong%3ESECURITY AND EEO STATEMENT%3C/strong%3E%3Cbr%3E%3Cbr%3E%3Cstrong%3ESecurity%3C/strong%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%3Cstrong%3EEEO%3C/strong%3E%3Cbr%3EUT 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.%3Cbr%3E%26nbsp;%3C/p%3E
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