Senior Clinical Trial Assistant

Position Summary:

The Senior Clinical Trial Assistant (Sr. CTA) is a remote role that will report to the Vice President, Clinical Operations or designee and will support the activities of the clinical operations team that includes data management to ensure timely start-up and smooth maintenance of operational and regulatory requirements of clinical studies from study initiation through study closeout.

Essential Duties and Responsibilities:

• Develop, update, and maintain clinical systems within project timelines
• Prepare, handle, distribute, file, and archive clinical documentation and reports
• Review study files periodically for accuracy and completeness
• Prepare, handle and distribute Clinical Trial Materials and maintenance of tracking information
• In collaboration CROs, manage eTMFs to ensure appropriate eTMF maintenance and audit readiness during the lifetime of a given study
• Assist with data review and collection
• Assist with data management UAT, reports and query processing
• Review vendor meeting minutes and prepare meeting agendas as applicable
• May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
• Perform administrative tasks to support team members with clinical trial execution as needed

Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent
• At least 3 years CTA experience along with working with data management and vendors
• Must have strong knowledge of DIA eTMF structure, EDC platforms (i.e., Medidata Rave, Medrio, etc.) and FDA/ICH/GCP guidelines
• Must have excellent interpersonal, written/verbal communication skills, administrative skills, organizational skills, and computer ability
• Strong computer skills in the following programs: MS Word, PowerPoint, and Excel
• Ability to “roll up your sleeves” and individually contribute results to department goals
• Ability to align with West Coast business hours