Summary

The Clinical Trial Associate/Sr. Clinical Trial Associate (CTA/Sr CTA), Clinical Operations is responsible for supporting the operational aspects of multiple studies across all stages of a trial (planning, start-up, execution, data analysis, reporting and closure). Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, meeting arrangement / minute capture, document management, and investigator meeting set-up and coordination. The CTA/Sr. CTA, as a key member of the study team is expected to provide the needed support to achieve operational deliverables.

Key Responsibilities / Essential Functions

• Participate in team meetings and prepare meeting agendas and minutes.
• Capture meeting action items and track activity status to closure.
• Develop, setup, and maintain study tracking tools for assigned trials to monitor study progress
• Prepare and maintain study progress data as appropriate (e.g., Key Performance Indicators), and prepare study progress reports as necessary
• Track study-related invoices and payments, and other financial information as needed
• Assist in the creation of study materials including study documents, site and patient facing materials, and presentations
• Contribute to the development and/or review of select study plans
• Distribute trial-related materials to sites and/or study team members
• Manage clinical study documents including reviews for completion, accuracy, and expiration
• Coordinate the collection and review of essential documents to authorize initial investigational product shipment and site activation
• Conduct periodic quality assessments of a vendor managed Trial Master File for outsourced studies
• Support the maintenance of the Trial Master File for sponsor-generated documents, and assist in quality assessments as appropriate
• Participate in CRF development and edit check testing
• Participate in user acceptance testing of study systems
• Participate in functional, cross-functional, and organizational initiatives
• Perform other activities as assigned

Basic Qualifications

• Education: Bachelor’s degree in science or related field
• Experience: Clinical research experience in industry (sponsor or CRO) is required.
• Preferred: CCRP training / certification

Other Requirements

• General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
• Advanced knowledge of clinical study processes
• Basic understanding of the Trial Master File reference model and the ability to navigate an eTMF
• Highly proficient in MS Office applications
• Well organized and detail oriented with strong written and verbal communication skills
• Effective time management and organizational skills
• Significant attention to detail
• Highly effective interpersonal skills