Clinical Trial Assistant

The Clinical Trial Assistant position reports to the CTA Manager. CTAs provide general logistical support for clinical trials, such as preparing meeting agendas and minutes, assisting with preparation of study site supplies and correspondence and maintenance of the Trial Master File.

Essential Duties and Responsibilities

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instruction.

• Assists Clinical Monitoring staff with site management activities, including serving as a project team liaison for sites on assigned studies, and communicating with sites as directed.

• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits. Prepares and maintains site manuals, reference tools and other documents. Maintains, updates, and inputs clinical tracking information into relevant CRC systems.

• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client. Manages shared mailbox, processes site requests and routes correspondence appropriately.

• Coordinates the ordering, packaging, shipping, and tracking of site supplies and materials. Assists with coordination of team meetings, attends meetings, and prepares agenda, meeting minutes, and action items.

• Perform other duties as assigned.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.

• Minimum 2 years’ experience in clinical research, academic, hospital or similar setting preferred.

• Ability to work independently with minimal supervision.

• Strong organizational skills.

• Proficiency in Microsoft Office and Adobe.

• Excellent verbal and written communication skills.

• Strong attention to detail.

• Ability to travel up to <10%.