UT Southwestern Medical Center
Regulatory Associate, Pediatrics Research
UT Southwestern Medical Center, Dallas, Texas, United States, 75215
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
IRB submission, Study modifications, Continuing Review IRB submissions, working closely with the external CROs, academic institutions and other studies sponsor to prepare regulatory documents to get the IRB approval. 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 EXPERIENCE AND EDUCATION Required Education Bachelor\'s Degree or equivalent Experience 2 years of related experience May consider experience and education in lieu of requirements. JOB DUTIES
Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. 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.
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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
IRB submission, Study modifications, Continuing Review IRB submissions, working closely with the external CROs, academic institutions and other studies sponsor to prepare regulatory documents to get the IRB approval. 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 EXPERIENCE AND EDUCATION Required Education Bachelor\'s Degree or equivalent Experience 2 years of related experience May consider experience and education in lieu of requirements. JOB DUTIES
Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. 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.
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