Perform regulatory processes necessary to make oncology clinical trials available to childhood cancer patients following federal regulations, as well as sponsor and University policies. This includes: creating and maintaining regulatory documents, ensuring all are filed and archived properly; 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 and external); addressing issues of study rationale, implementation, and safety monitoring; monitoring trends in regulatory/protocol processes and making recommendations for improvement; and serving as a resource to improve research compliance within the Pediatric Oncology group.
40% Regulatory Processes for Continued Management of Active Trials •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. •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 •Ensure all regulatory reporting requirements are met
40% Regulatory Processes for Opening New Trials •Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management and eBinder systems. •In collaboration with the PI and Primary Research Coordinator, interpret study protocols and develop consent form documents, prepare IRB & CPRC 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.
10% Process Improvement •Serve as the primary regulatory resource for the research teams, research sponsors, and University review committees. •Support development of standardized research practices and workflows •Attend professional development and training sessions to ensure compliance with newest policies and procedures. •Monitor trends and offer suggestions for improvements •Support other special projects and program initiatives as directed
Mentorship and Training (10%) •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 •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
All required qualifications must be documented on application materials
Required Qualifications: •BA/BS in a related field, and four years of relevant experience; or a combination of related education and experience to total eight years •Experience with the federal regulations governing human subject research, including protections for vulnerable populations •Experience interpreting medical information and developing patient materials, such as consent forms and recruitment flyers •Experience preparing and managing IRB and other regulatory review submissions •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
Preferred Qualifications: •Previous experience as a Regulatory Specialist or Clinical Research Coordinator •Knowledge of medical and oncology terminology •Certification as a clinical research professional with Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or willingness to obtain certification at time of eligibility
Internal Number: 339287
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.