University of Minnesota Twin Cities
Regulatory Specialist
University of Minnesota Twin Cities, Minneapolis, Minnesota, United States, 55400
Are 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 on a mission to elevate the game of clinical and translational research, and we're looking for passionate individuals to join us on this exhilarating adventure!Clinical and Translational Research Services (CTRS) is not your typical support unit – we're a powerhouse of dynamic individuals dedicated to revolutionizing the landscape of research at the University of Minnesota. We thrive on collaboration, find inspiration in creative solutions, and always aim for excellence.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 within the group. You’ll be responsible for the regulatory processes necessary to make clinical trials available to patients following federal regulations, as well as the sponsor and University policies. This includes creating and maintaining regulatory documents, as well as adapting participant consent forms in compliance with sponsor and local standards. You’ll act as a liaison for the sponsor, principal investigator, research study teams, review committees, and monitors (internal & external) to the IRB; addressing issues of study rationale, implementation, and safety monitoring. Additionally, this position will monitor trends in regulatory/protocol processes and make recommendations for improvement. You will also play a key role in providing guidance to ensure regulatory documents are filed and archived, providing education, training, and serving as a resource to improve research compliance.Work location:
Hybrid; occasional on-site presence requiredSalary Range:
$68,000-$78,000DUTIES/RESPONSIBILITIES40% Regulatory Processes for Opening New TrialsCreating regulatory files for new studies.Completing IRB and other required review committee applications on assigned protocols.Drafting study-specific participant consent form documents according to sponsor and University requirements.Drafting study-related correspondence for study PI.Creating all required documents for assigned regulatory files.Assisting PI and research manager with coordination of regulatory activities relative to initiation of assigned clinical trials.Communicating with other University and hospital departments to collect needed information for initiating new trials and opening study research accounts.Assisting research team in preparation for audits/monitoring visits.35% Regulatory Processes for Continued Management of Active TrialsFacilitating continuing review compliance for IRB annual reviews.Processing study amendments and revising consent forms as needed.Communicating with department faculty and staff regarding pertinent changes to protocol-specific requirements.Communicating with other University and hospital departments regarding pertinent changes to protocol requirements.Preparing regulatory approval applications, responding to stipulations, and shepherding applications and correspondence through the processes until approvals are obtained.Tracking all regulatory review submissions and approvals to ensure deadlines are met.Providing guidance on the maintenance of regulatory documentation to ensure compliance and audit-readiness at any given time.10% Risk ManagementTriaging and documenting outside safety reports and local serious adverse events.Reporting unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline.Submitting Reportable New Information to the IRB within the required timeline.10% Process ImprovementAssisting in the development of standard operating procedures for regulatory processes.Entering information into study management database and creating accurate reports for the research team.Monitoring trends in regulatory/protocol processes and making recommendations for improvement.Assisting with implementing changes in regulatory processes as needed.5% Group Leadership, New Procedures, and Training of New StaffAssisting in identifying, developing, discussing, and implementing new procedures.Assisting with monitoring according to departmental procedures.Participating in the training of new staff as requested.Fulfilling special requests for data management and other duties as assigned.All required qualifications must be documented on application materials.Required QualificationsBS/BA and 4 years’ experience in clinical research setting or an advanced degree and 2 years’ experience or an equivalent combination of education and experience to total eight years.Relevant experience includes:Working in a clinical research setting.Submitting to an Institutional Review Board.Maintaining clinical research documentation.Preferred QualificationsBS/BA or Masters degree in a health related field.Additional professional experience on a clinical research project team or similar environment.Experience in an academic medicine setting.Work experience demonstrating ability to multitask and prioritize.Experience independently maintaining deadlines and prioritizing assignments.Work experience initiating and processing multiple projects simultaneously.Work experience providing customer service to internal and external clients.
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Hybrid; occasional on-site presence requiredSalary Range:
$68,000-$78,000DUTIES/RESPONSIBILITIES40% Regulatory Processes for Opening New TrialsCreating regulatory files for new studies.Completing IRB and other required review committee applications on assigned protocols.Drafting study-specific participant consent form documents according to sponsor and University requirements.Drafting study-related correspondence for study PI.Creating all required documents for assigned regulatory files.Assisting PI and research manager with coordination of regulatory activities relative to initiation of assigned clinical trials.Communicating with other University and hospital departments to collect needed information for initiating new trials and opening study research accounts.Assisting research team in preparation for audits/monitoring visits.35% Regulatory Processes for Continued Management of Active TrialsFacilitating continuing review compliance for IRB annual reviews.Processing study amendments and revising consent forms as needed.Communicating with department faculty and staff regarding pertinent changes to protocol-specific requirements.Communicating with other University and hospital departments regarding pertinent changes to protocol requirements.Preparing regulatory approval applications, responding to stipulations, and shepherding applications and correspondence through the processes until approvals are obtained.Tracking all regulatory review submissions and approvals to ensure deadlines are met.Providing guidance on the maintenance of regulatory documentation to ensure compliance and audit-readiness at any given time.10% Risk ManagementTriaging and documenting outside safety reports and local serious adverse events.Reporting unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline.Submitting Reportable New Information to the IRB within the required timeline.10% Process ImprovementAssisting in the development of standard operating procedures for regulatory processes.Entering information into study management database and creating accurate reports for the research team.Monitoring trends in regulatory/protocol processes and making recommendations for improvement.Assisting with implementing changes in regulatory processes as needed.5% Group Leadership, New Procedures, and Training of New StaffAssisting in identifying, developing, discussing, and implementing new procedures.Assisting with monitoring according to departmental procedures.Participating in the training of new staff as requested.Fulfilling special requests for data management and other duties as assigned.All required qualifications must be documented on application materials.Required QualificationsBS/BA and 4 years’ experience in clinical research setting or an advanced degree and 2 years’ experience or an equivalent combination of education and experience to total eight years.Relevant experience includes:Working in a clinical research setting.Submitting to an Institutional Review Board.Maintaining clinical research documentation.Preferred QualificationsBS/BA or Masters degree in a health related field.Additional professional experience on a clinical research project team or similar environment.Experience in an academic medicine setting.Work experience demonstrating ability to multitask and prioritize.Experience independently maintaining deadlines and prioritizing assignments.Work experience initiating and processing multiple projects simultaneously.Work experience providing customer service to internal and external clients.
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