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.

Responsibilities:

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