Regulatory Processes for Opening New Clinical Studies (50%)
Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management and eBinders systems.
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.
Support the development of electronic consent forms in REDcap
Prepare for and participate in site selection and site initiation visits.
Regulatory Management of Ongoing Clinical Studies (40%)
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 and eBinder systems.
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.
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
Support the team in ensuring all regulatory reporting requirements are met
Research Operations and Process Improvement (5%)
Serve as a regulatory resource for the research teams, research sponsors, and University review committees.
Support the implementation of an eBinder system
Attend professional development and training sessions to ensure compliance with newest policies and procedures.
Support other special projects and program initiatives as directed
Mentorship and Training (5%)
Mentor Clinical Research Coordinators in Regulatory Management of human subject's research
Assist in identifying, developing, discussing, and implementing new procedures
Assist with quality monitoring according to departmental procedures
***All required qualifications must be documented on application materials***
BA/BS in a related field, and two years of relevant experience; or a combination of related education and experience to total six years
Experience with the federal regulations governing human subject research, including protections for vulnerable populations
Experience interpreting clinical research protocols.
Computer proficiency, and ability to navigate multiple software applications.
Electronic document management experience and strong 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
Experience preparing and managing IRB and other regulatory review submissions
Clinical Research certification, or willing to sit for exam within 6 months of hire
Previous professional experience on a clinical research project team or similar environment
Experience writing and adapting patient consent forms for research studiesâ¯
Experience in an academic medicine setting
Internal Number: 338614
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.