Clinical Trial Assistant I

Role Summary

The Clinical Trial Assistant I will support the study team in ensuring the most effective and efficient conduct of clinical research projects. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities

• Assist with the distribution of key study documents such as investigator brochures, protocols, informed consent forms, interim safety reports, and site educational and reference material
• Assist with formatting and production of site facing materials
• Assist project team with study specific documentation, including filing to the Trial Master File and/or Clinical Trial Management System
• Maintain and perform routine reviews of the Trial Master File
• Assist the project team with investigator recruitment by obtaining confidentiality agreements, forwarding study synopsis to sites, and distribution of feasibility questionnaires
• Assist project team with gathering agenda topics, preparing agenda, scheduling meetings, attend and generate project meeting minutes
• Facilitate collection of regulatory documents for initial internal IP and regulatory release
• Coordinate collection, tracking, and maintenance of updated site regulatory documentation
• Assist in collating materials for investigator, scientific meetings, and conferences, including invitations, agendas, and materials distribution
• Track and ship (as needed) study supplies provided by Corcept and study specific vendors
• Set up and maintain study tracking tools with the oversight of the manager
• Develop working knowledge of company standard operating procedures (SOPs) and FDA regulations related to clinical studies
• Provide general administrative support to the Clinical Operations Department
• Other duties as assigned by the manager

Qualifications

• Familiarity with applicable regulatory requirements, Good Clinical Practice/ICH, and Good Documentation Practices
• Ability to read and understand scientific literature
• Excellent verbal and written communication skills
• Strong proficiency in Microsoft Office Suite
• Ability to work as part of a multifunctional team

Education

• BA/BS or equivalent work experience
• 0-2 year’s experience in pharma related industry