The Clinical Trials Assistant (CTA) will be responsible for providing operational/administrative support to the Clinical Affairs team for the day-to-day execution of clinical trials. The position will assist in organizing different stages of clinical trials following established SOPs, Good Clinical Practice (GCP) and applicable regulatory regulations in the execution of all study activities. The CTA’s main responsibilities are to maintain the study’s Electronic Trial Master Files (eTMF), ensure quality, and track the status of study documents,  study-specific training for team members and study sites, capture study-specific meeting minutes, produce study-specific binders, and interface with study vendors and site study staff.

What you will be responsible for: 

• Assist in the planning, coordination, and execution of clinical trials to ensure compliance with FDA Regulations, ICH-GCP Guidelines, and company SOPs.
• Manage  clinical trials Electronic Trial Master File (eTMF) and Investigator Site File (ISF) including set-up of eTMF, collection of clinical trial documents, QC and review of all study specific documents received from study sites and CRA(s), filing, and ensuring all files are up to date and accurate.
• Ensure eTMF is audit and inspection ready.
• Manage  radiographic images completed for clinical trials, including collection, review, and working with outside radiologist(s) on reads, managing radiographic vendors, and providing radiographic data to internal stakeholders.
• Assist with study document processing, including review and QC, formatting study documents, and assisting with other reviews as requested.
• Prepare and maintain study specific Regulatory Binders and Subject Binders for delivery to study sites.
• Coordinate archiving of completed studies.
• Assist with study site communication and tracking study progress.
• Maintain, prepare, and distribute study materials such as Instructions for Use, protocols, informed consent forms, study manuals, source document worksheets, and any other study materials as requested.
• Maintain study-specific training documentation for Clinical Affairs and Study Site teams, ensuring appropriate documentation is obtained and filed.
• Coordinate Institutional Review Board (IRB) submissions and approvals.
• Contribute to the preparation of study reports, regulatory submissions, presentations, and posters as requested.
• Schedule and participate in weekly team meetings, prepare, and distribute meeting agendas, materials, and minutes.
• Assist with scheduling monitoring visits on team calendar.
• Assist with user acceptance testing of clinical study electronic data capture system(s).
• Supports maintenance of department SOPs and work instructions.
• Complete other tasks and projects assigned by the Clinical Project Manager and/or Director, Clinical Affairs.
• Ensure all study activities are conducted in compliance with Good Clinical Practice (GCP) Guidelines

• BS or BA degree in a medical, scientific, or health-related discipline is strongly preferred, with 0-2 years of related clinical experience. In lieu of degree, a HS Diploma with 3+ years of clinical experience is required.
• Ability and willingness to travel (up to 15%)

All your information will be kept confidential according to EEO guidelines.

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