University of Minnesota - 15th Ave
Regulatory Specialist
University of Minnesota - 15th Ave, Minneapolis, Minnesota, United States, 55400
University of Minnesota - Regulatory Specialist
Location: Minneapolis, MinnesotaJob ID: 363763Job Family: Research-SupportFull/Part Time: Full-TimeRegular/Temporary: RegularJob Code: 8352P3Employee Class: Civil ServiceAbout the JobAre you ready to embark on a transformative journey in clinical and translational research? As part of the University of Minnesota's Clinical and Translational Research Services, we are passionate about research; transforming possibilities and driving innovation. We're looking for passionate individuals to join us!About the RoleThe Regulatory Specialist is an important role in the Clinical Research Support Center at the University of Minnesota, facilitating the compliant execution of clinical trials, and assisting in the development and maintenance of regulatory standards. Responsibilities include:Creating and maintaining regulatory documents for clinical trials.Acting as a liaison for the sponsor, principal investigator, and research study teams.Monitoring trends in regulatory/protocol processes.Providing education and training to improve research compliance.Duties/ResponsibilitiesRegulatory Processes for Opening New Trials (40%)Creating regulatory files for new studies, completing IRB applications, drafting participant consent forms, and assisting with regulatory activities.Regulatory Processes for Continued Management of Active Trials (35%)Facilitating continuing review compliance, processing study amendments, and tracking regulatory submissions.Risk Management (10%)Documenting safety reports, reporting unanticipated problems, and submitting required information to the IRB.Process Improvement (10%)Assisting in the development of standard operating procedures and monitoring trends for improvement.Group Leadership and Training (5%)Assisting in the development and implementation of new procedures and training of new staff.QualificationsAll required qualifications must be documented on application materials.Required QualificationsBS/BA and 4 years' experience in clinical research or an advanced degree and 2 years' experience, or an equivalent combination of education and experience.Preferred QualificationsBS/BA or Master's degree in a health-related field, experience on a clinical research project team, and experience in an academic medicine setting.About the DepartmentThe University of Minnesota Clinical and Translational Science Institute (CTSI) aims to accelerate and improve clinical and translational science research and education.BenefitsWorking at the University of Minnesota offers a flexible work environment, competitive wages, and a comprehensive benefits package.The University recognizes and values the importance of diversity and inclusion in enriching the employment experience. The University is committed to attracting and retaining employees with varying identities and backgrounds.
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Location: Minneapolis, MinnesotaJob ID: 363763Job Family: Research-SupportFull/Part Time: Full-TimeRegular/Temporary: RegularJob Code: 8352P3Employee Class: Civil ServiceAbout the JobAre you ready to embark on a transformative journey in clinical and translational research? As part of the University of Minnesota's Clinical and Translational Research Services, we are passionate about research; transforming possibilities and driving innovation. We're looking for passionate individuals to join us!About the RoleThe Regulatory Specialist is an important role in the Clinical Research Support Center at the University of Minnesota, facilitating the compliant execution of clinical trials, and assisting in the development and maintenance of regulatory standards. Responsibilities include:Creating and maintaining regulatory documents for clinical trials.Acting as a liaison for the sponsor, principal investigator, and research study teams.Monitoring trends in regulatory/protocol processes.Providing education and training to improve research compliance.Duties/ResponsibilitiesRegulatory Processes for Opening New Trials (40%)Creating regulatory files for new studies, completing IRB applications, drafting participant consent forms, and assisting with regulatory activities.Regulatory Processes for Continued Management of Active Trials (35%)Facilitating continuing review compliance, processing study amendments, and tracking regulatory submissions.Risk Management (10%)Documenting safety reports, reporting unanticipated problems, and submitting required information to the IRB.Process Improvement (10%)Assisting in the development of standard operating procedures and monitoring trends for improvement.Group Leadership and Training (5%)Assisting in the development and implementation of new procedures and training of new staff.QualificationsAll required qualifications must be documented on application materials.Required QualificationsBS/BA and 4 years' experience in clinical research or an advanced degree and 2 years' experience, or an equivalent combination of education and experience.Preferred QualificationsBS/BA or Master's degree in a health-related field, experience on a clinical research project team, and experience in an academic medicine setting.About the DepartmentThe University of Minnesota Clinical and Translational Science Institute (CTSI) aims to accelerate and improve clinical and translational science research and education.BenefitsWorking at the University of Minnesota offers a flexible work environment, competitive wages, and a comprehensive benefits package.The University recognizes and values the importance of diversity and inclusion in enriching the employment experience. The University is committed to attracting and retaining employees with varying identities and backgrounds.
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