Trial operations. With supervision, manage single- and multi-site clinical research projects including study start-up, daily operations, communication with the collaborating site and device partner, recruitment and enrollment tracking against NIH milestones, troubleshooting, quality assurance and quality control, and study close-out. Coordinate device delivery, training and session scheduling with the device manufacturer; maintain device accountability records. May include study visits and procedures when needed to meet the needs of the project.
Regulatory and study documentation. Develop, create and review regulatory submissions and study documents and tools, including protocols, consent forms, IRB modifications and continuing reviews, annual reports, source documents, training materials, manuals of procedures, Data and Safety Monitoring Board charters and meeting packets, case report forms and standard operating procedures. Maintain the regulatory binder and the abbreviated IDE file (21 CFR 812 records and reporting), support sponsor-investigator registration with the Penn Medicine Office of Clinical Research, and manage ClinicalTrials.gov registration and results reporting. Provide assistance with investigational new drug, investigational device and clinical trial agreement determinations.
Finance and grants. Assist with pre-award activities (clinical trials management system registration, Medicare coverage analysis where applicable, research billing numbers, contract and agreement timelines, budget input, grant-writing assistance) and post-award activities (invoicing, subaward and consultant billing review, purchasing of study equipment and supplies). Support NIH reporting, including annual progress reports (RPPR), recruitment milestone reports and NIMH Data Archive submissions.
Staff supervision and training. Assist and train direct and indirect clinical research staff in program, division and department procedures as required per protocol, including onboarding, data and lab management in the study’s 21 CFR Part 11-compliant data system (PennCRMS), protocol compliance, quality control and quality assurance, human subjects protection, Good Clinical Practice, project assignments, staff mentoring and bi-annual performance appraisal completion.
Other duties as assigned.