Responsibilities

Regulatory Processes for Opening New Clinical Studies (40%) 

• 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 submissions, and respond to requests for modifications.
• Facilitate accurate and timely completion of additional regulatory documents.
• Support the development of electronic consent forms in REDcap
• 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 (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.
• 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

Research Operations and Process Improvement (10%)

• 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