Job Description:

• Assist and support in the planning and execution of clinical trials and research projects in accordance with designated timelines and budgets
• Manage components of projects, under the direction of senior study manager
• Assist in the preparation and oversee distribution of study documents and materials including data collection forms, manuals of operations and technical memos to research sites
• Assemble and distribute various materials, including study supplies and data collection forms, to clinical sites
• Coordinate and schedule conference calls; write and distribute meeting minutes
• Manage correspondence and project communications
• Assist in the preparation and updating of progress reports and client/study/network meeting materials
• Assist with the preparation of site or investigator training materials; participate and/or assist with trainings for clinical study staff
• Collaborate with data management team to develop and implement data collection and management strategies
• Participate in quality control activities
• Monitor risks and implement mitigation strategies
• Gather background data and information to support proposal and project efforts

Requirements:

• Bachelor's Degree and 3 years of experience, Master's degree and 1 years of experience, or equivalent combination of education and experience
• Must have experience supporting clinical trial operations
• Supporting Data Coordinating Center work is preferred
• Previous experience supporting IND or regulated studies is a plus
• Proficiency with MS Word, Outlook, PowerPoint, Excel
• Demonstrated interest in health or clinical research
• Ability to work in a highly collaborative environment
• Ability to listen and communicate well both verbally and in writing
• Ability to synthesize and summarize complex information
• Ability to work independently
• Attention to detail and accuracy
• Ability to handle regular changes to priorities, interruptions to independent work due to meetings, and multiple tasks ongoing simultaneously
• Ability to have regular, reliable and predictable attendance
• Ability to travel as needed (typically less than 10%) to committee meetings, scientific meetings, project meetings, and research sites

Benefits:

• Competitive base salary
• Generous paid time off policy
• Merit based annual increases
• Bonus opportunities
• Robust recognition program
• Health insurance plans (including dental, life, short-term and long-term disability)
• Access to retirement savings program (401(k) plan)
• Paid parental leave for all parents
• Financial assistance with adoption expenses or infertility treatments
• Financial reimbursement for education and developmental opportunities
• Employee assistance program
• Numerous other offerings to support a healthy work-life balance