The Clinical Trial Assistant (CTA) provides essential administrative and operational support to the Clinical Operations team, ensuring the efficient planning, conduct, and documentation of clinical research studies. This role ensures compliance with Good Clinical Practice (GCP) guidelines, company Standard Operating Procedures (SOPs), and applicable regulatory requirements throughout all stages of clinical trials.
• Provide general administrative support to the Clinical Department and project teams.
• Assist in coordinating and completing tasks required to meet departmental and project milestones.
• Support the conduct of ongoing clinical studies, ensuring all documentation is prepared, handled, distributed, filed, and archived in line with SOPs and regulatory standards.
• Conduct regular quality checks of study files to ensure accuracy and completeness.
• Assist Clinical Research Associates (CRAs) and Clinical Trial Managers (CTMs) with preparation, tracking, and distribution of clinical trial supplies and materials.
• Process and track Data Collection Forms, ensuring proper logging, quality control, and secure filing.
• Manage documentation related to protocol amendments and distribution of final study documents (e.g., investigator lists, Investigator’s Brochure, protocols, informed consent templates, final data forms).
• Organize and coordinate study-related meetings (in-person or virtual), prepare agendas, record minutes, and follow up on action items.
• Support the creation and maintenance of study materials, including site and CRA training documents, regulatory templates, study binders, communications, and presentations.
• Handle shipments of study-related materials to sites, vendors, CRAs, and internal teams.
• Assist with planning, preparation, and on-site support for investigator meetings and other study-related events.