Clinical Research Assistant

• Assisting with protocol and consent development under supervision, coordinating the activities of daily operations of clinical research studies
• Organizing and scheduling study participants for study visits or procedures
• Communicating schedule of study events with research families and serve as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them throughout each phase of the study
• Assisting the PI during patient visits
• Collecting study specimens at the bedside and operating room and delivering or shipping to appropriate locations
• Maintaining regulatory and subject binders, case report forms, and other study documents
• Writing study submissions to the Internal Review Board (IRB), U.S. Food and Drug Administration (FDA),and Data Safety Monitoring Committee (DSMC), including amendments and reportable events
• Maintaining patient sample organization and inventory
• Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis
• May write articles and summaries of studies for submission
• May present study results at local and national meetings
• Participates in the training of newly hired research study assistants, as required
• Performs other miscellaneous administrative duties as assigned or required

• Bachelor’s degree
• Strong communication skills to effectively communicate with families/parents/study participants to explain the study, recruit and schedule, and provide them with accurate information
• Good analytical skills to collect information from diverse sources
• Well-developed writing skills and the ability to work independently are also needed
• Experience with human subject clinical trials is a plus
• Successful candidates will be highly collaborative, passionate about innovative medicine, self-motivated, organized, and have good people skills
• Minimum of a 2-year commitment required

Experience with human subject clinical trials is a plus

• flexible schedules
• affordable health, vision and dental insurance
• child care and student loan subsidies
• generous levels of time off
• 403(b) Retirement Savings plan
• Pension
• Tuition and certain License and Certification Reimbursement
• cell phone plan discounts
• discounted rates on T-passes