The Regulatory Specialist facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory standards within the group. The Regulatory Specialist is an employee of the Clinical Translational Science Institute (CTSI). The Regulatory Specialist is an important role in the new Clinical Research Support Center at the University of Minnesota.
Responsibilities include: Perform regulatory processes necessary to make clinical trials available to patients following federal regulations, as well as sponsor and University policies. This includes: creating and maintaining regulatory documents, creating and adapting subject consent forms in compliance with sponsor and local standards; acting as a liaison with sponsor, principal investigator, research manager, review committees and monitors (internal & external); addressing issues of study rationale, implementation, and safety monitoring; monitoring trends in regulatory/protocol processes and making recommendations for improvement; providing guidance to ensure regulatory documents are filed and archived properly; and providing education, training and serving as a resource to improve research compliance.
40% Regulatory Processes for Opening New Trials: - Creates regulatory files for new studies - Completes IRB and other required review committee applications on assigned protocols - Drafts study-specific subject consent form documents according to sponsor and University requirements - Drafts study-related correspondence for study PI - Creates all required documents for assigned regulatory files - Assists PI and research manager with coordination of regulatory activities relative to initiation of assigned clinical trials - Communicate with other University and hospital departments to collect needed information for initiating new trials and opening study research accounts - Assist research team in preparation for audits/monitoring visits
35% Regulatory Processes for Continued Management of Active Trials: - Facilitates continuing review compliance for IRB annual reviews - Process study amendments and revise consent forms as needed - Communicate with department faculty and staff regarding pertinent changes to protocol-specific requirements - Communicate with other University and hospital departments regarding pertinent changes to protocol requirements - Prepare regulatory approval applications, respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained - Track all regulatory review submissions and approvals to ensure deadlines are met - Provide guidance on the maintenance of regulatory documentation to ensure compliance and audit-ready at any given time
10% Risk Management: - Coordinate the processing of outside safety reports and local serious adverse events - Reports unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline
10% Process Improvement: - Assist in the development of standard operating procedures for regulatory processes - Enters information into study management database and creates/prints accurate reports for the research team - Monitors trends in regulatory/protocol processes and makes recommendations for improvement - Assist with implementing changes in regulatory processes as needed
5% Group Leadership, New Procedures, and Training of New Staff: - Assist in identifying, developing, discussing, and implementing new procedures - Assist with monitoring according to departmental procedures - Participate in the training of new staff as requested - Fulfill special requests for data management and other duties as assigned
Required Qualifications (must be mentioned on application/resume): - BS/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. - Experience working in a clinical research setting - Experience submitting to an Institutional Review Board. - Experience independently maintaining deadlines and prioritizing assignments. - Experience with computerized data management in a professional setting. - Work experience in verbal and written communication. - Work experience initiating and processing multiple projects simultaneously. - Experience in a PC environment including Microsoft Office Word and Excel. - Work experience documenting situations clearly and concisely in written communications. - Work experience providing customer service to internal and external clients.
Preferred Qualifications: - BS/BA 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.
Internal Number: 334226
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.