The purpose of this position is to manage and coordinate all regulatory components of multiple clinical trials and studies conducted by faculty members within the Center for Pediatric Obesity Medicine. This includes: creating and maintaining regulatory documents, ensuring all are filed and archived properly; creating and adapting protocols and 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; and providing education, training and serving as a resource to improve research compliance.
40% Study Start-Up • Creates regulatory files for new studies • Completes IRB, FDA and HIPCO and other required review committee applications on assigned protocols • Drafts study-specific subject consent form and protocol documents according to sponsor and University requirements • Drafts study-related correspondence for study PI • Creates and maintains all required documents for assigned regulatory files • Assists PI and research manager with coordination of all activities relative to initiation of assigned clinical trials • Communicate with other University and ancillary departments to initiate new trials and establish study research accounts • Assist research team in preparation for audits/monitoring visits
40% Regulatory Processes for Continued Management of Active Trials • Facilitate continuing review compliance for IRB and other annual reviews • Process study amendments and revise protocol/consent forms as needed • Communicate with department faculty and staff regarding pertinent changes to protocol-specific requirements • Communicate with other University departments, Sponsors and other agencies regarding pertinent changes to protocol requirements • Archive study files when appropriate • Assist with study drug inventory and accountability
10% Process Improvement • Assist in the development of standard operating procedures for regulatory processes • Enter information into study management database and create accurate reports for the research team • Monitor trends in regulatory/protocol processes and make recommendations for improvement • Assist with implementing changes in regulatory processes as needed
• 10% 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
All required qualifications must be documented on application materials.
Required Qualifications: • BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years • Demonstrated ability to work independently, maintain deadlines, and prioritize assignments • Experience with computerized data management in a professional setting • Detail oriented with excellent verbal and written communication skills • Ability to initiate and process multiple projects simultaneously • Professional experience on a clinical research project team or similar environment • Experience writing and adapting protocols and patient consent forms for research studies • Knowledge of regulations governing research activity (such as GCPs, FDA regulations and ICH guidelines) • Computer proficiency in a PC environment including Microsoft Office products such as Word, Excel, and Powerpoint • Ability to express ideas/document situations clearly and concisely in written communications • Demonstrated ability to provide excellent customer service to internal and external clients
Preferred Qualifications: • BA/BS in health related field • Experience with ETHOS • Experience with OnCore • Previous experience in an academic setting
Internal Number: 322570
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.