Position Summary: The primary purpose of this position is to support pediatric clinical studies according to regulatory requirements, institutional guidelines, and sponsor expectations. The Regulatory Specialist facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory standards within the group. Duties include comprehensive regulatory management of active and new clinical studies, facilitating study start-up, ensuring compliance with University reporting requirements, and maintaining records of investigator and staff qualifications. This position reports to the Clinical Research Program Director, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team.
Responsibilities/duties: Regulatory Processes for Opening New Clinical Studies (45%) •Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management System. •In collaboration with the PI and Primary Research Coordinator, interpret study protocols and develop consent form documents, prepare IRB submissions, and respond to requests for modifications. •Facilitate accurate and timely completion of additional regulatory documents. •Shepherd submissions and correspondence through the processes until approvals are obtained. •Create regulatory files and binders for new studies. •Prepare for and participate in site selection and site initiation visits.
Regulatory Management of Ongoing Clinical Studies (45%) •Ongoing regulatory management including preparation and submission of protocol amendments and other changes, and ensuring timely annual reviews. •Maintaining protocol information and documents in the Clinical Trials Management System. •Facilitate completion of additional regulatory documents. •Track IRB submissions, approvals, and pending expirations; ensure deadlines are met to avoid a lapse in approval. •Maintain version control of all IRB-approved study documents. •Coordinate processing of outside safety reports and local serious adverse events. •Maintain regulatory binders and required documentation to ensure compliance with regulations, University policies, and Sponsor expectations. •Prepare for and participate in monitoring visits, program audits, etc. •Coordinate processing of outside safety reports and local serious adverse events; ensure PI assessment per IRB and sponsor requirements •Report Unanticipated Problems Involving Risk to Subject and Others (UPIRTSO) per IRB requirements
Research Operations and Process Improvement (5%) •Serve as the primary regulatory resource for the research teams, research sponsors, and University review committees. •Attend professional development and training sessions to ensure compliance with newest policies and procedures. •Support development of standardized research practices and workflows •Monitor trends and offer suggestions for improvements •Support other special projects and program initiatives as directed
Mentor-ship and Training (5%) •Mentor Clinical Research Coordinators in Regulatory Management of human subjects research •Assist in identifying, developing, discussing, and implementing new procedures •Assist with quality monitoring according to departmental procedures •Participate in the training of new staff as requested
All required qualifications must be documented on application materials.
Required qualifications: •BA/BS in a related field and two years of relevant experience; or a combination of related education and work experience to total six years •Experience in the conduct of human subjects research •Understanding of the federal regulations governing human subject research, including protections for vulnerable populations •Computer proficiency, and ability to navigate multiple software applications. •Electronic document management experience and strong experience and skills with Adobe and Microsoft Word •Detail-oriented with exceptional organizational, planning and problem-solving skills •Ability to work independently, as a part of a team and with changing priorities •Demonstrated ability to maintain deadlines and prioritize assignments •Excellent written, verbal and interpersonal skills
Internal Number: 327091
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.