The Pediatric Hematology/Oncology program seeks a Regulatory Specialist to facilitate the compliant execution of clinical trials, including assistance with development and maintenance of regulatory standards within the group.
Responsibilities include: 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 & 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.
30% Regulatory Processes for Opening New Trials • Creates regulatory files for new studies • Completes IRB, CPRC and other required review committee applications on assigned protocols • Drafts study-specific subject consent form 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 hospital departments to collect needed information for initiating new trials and opening study research accounts • Assist research team in preparation for audits/monitoring visits
60% Regulatory Processes for Continued Management of Active Trials • Facilitates continuing review compliance for IRB and CPRC annual reviews • Process study amendments and revise consent forms as needed • Communicate with department faculty and staff regarding pertinent changes to protocol-specific requirements • Communicate with other University and hospital departments regarding pertinent changes to protocol requirements • Archives study files when appropriate
10% Process Improvement • Assist in the development of standard operating procedures for regulatory processes • Enters information into study management database and creates/prints accurate reports for the research team • Monitors trends in regulatory/protocol processes and makes recommendations for improvement • Assist with implementing changes in regulatory processes as needed • 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.
BA/BS with at least 2 years of experience or a combination of related education and work experience to equal six years
Minimum of one (1) year experience in a clinical research setting
Experience with computerized data management in a professional setting
Working knowledge of regulations governing research activity (such as GCPs, FDA regulations and ICH guidelines)
Demonstrated ability to initiate and process multiple projects simultaneously
Demonstrated ability to work independently, maintain deadlines, and prioritize assignments
Proficiency with Microsoft Word, Excel, Powerpoint
Excellent verbal and written communication skills
Demonstrated ability to provide excellent customer service to internal and external clients
Professional experience on a clinical research project team
Experience in an academic medicine setting
Experience writing and adapting patient consent forms for clinical research studies
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
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.