Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Clinical Research Regulatory/Budget Specialist The Clinical Research Regulatory/Budget Specialist facilitates the compliant execution of clinical trials by creating budgets, reviewing contracts, and assist in the development and maintenance of regulatory submissions and documents within the group. The person in this position will work with the research team at the Pulmonary, Allergy, Critical Care and Sleep Division in the Department of Medicine.
Duties/Responsibilities Regulatory processes and management of studies: (60%) • Create, maintain, and upload regulatory documents in OnCore and gather required documents and approvals prior to the deadline. • Completes IRB and other required review committee applications on assigned protocol and facilitates continuing IRB annual reviews • Assists research team with coordination of all activities relative to initiation of assigned clinical trials such as new trials and opening study research accounts • Communicate with other University departments and clinical partners pertinent changes to protocol requirements • Maintain regulatory documentation to ensure compliance and audit-ready at any given time • Assist research team in preparation for audits/monitoring visits • Reports unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline • Draft, process, and amend study- specific consent forms and ensuring the University requirements are met. • Coordinate the processing of outside safety reports and local serious adverse events • Drafts study-related correspondence for study investigator • Facilitate study close out actions then archive as appropriate • Assist in the development of standard operating procedures for regulatory processes • Monitors trends in regulatory/protocol processes, makes recommendations for improvement, and assist with implementing changes in regulatory processes as needed
Budgetary management (35%) • Collaborate with research study staff (Investigators, Coordinators, Project Managers, etc.) to review the study protocol and develop the study budget to ensure that all relevant study costs have been included. Negotiate contract payment terms and amounts with the sponsor for industry-sponsored studies. • Ensure timely processing of all pre-award steps to avoid delays in starting trials. • Compare protocol and contract documents for consistency. • Act as a liaison with the Sponsored Project Administration (SPA) department and academic department finance/administration to facilitate communications, ensure document submissions, and resolve any contract issues. • Account initiation, project set-up, ongoing involvement during study conduct • Work to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants. • Set up purchase orders and pay study related invoices. • Work with post-award accountants to ensure accurate invoicing completed.
Group Leadership, New Procedures, and Training of New Staff (5%) • Assist in identifying, developing, discussing, and implementing new 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 documented in application materials) • BS/BA and 2 years’ experience or an equivalent combination of education and experience to total 6 years. • Experience independently meeting 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 • Experience completing and submitting regulatory documents (IRB applications, continuing reviews, other required regulatory reporting, etc). • Experience working with Institutional Review Boards. • Knowledgeable on federal regulations and good clinical practice. • Experience maintaining regulatory binders. • Experience in an academic medicine setting.
Internal Number: 340956
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.