Clinical Trial Assistant I

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Assistant I based in Canada.** This role provides an opportunity to support the successful execution of clinical research studies within a fast-paced healthcare environment. You will collaborate with clinical operations teams, study sponsors, investigational sites, and vendors to ensure trials are delivered efficiently and according to regulatory standards. The position focuses on maintaining essential documentation, supporting trial coordination, and enabling high-quality clinical trial operations. You will contribute to the organization and oversight of clinical trial activities while gaining valuable experience in pharmaceutical, biotechnology, and medical device research. Working alongside experienced clinical professionals, you will help ensure study compliance, operational accuracy, and timely delivery of clinical milestones. This opportunity is ideal for an organized and detail-oriented professional looking to build a career in clinical research and trial management. ### Accountabilities: As a Clinical Trial Assistant I, you will support clinical operations activities by coordinating documentation, tracking study progress, and assisting project teams throughout the clinical trial lifecycle. Your responsibilities will include: - Collaborating with study sponsors, investigational sites, vendors, and internal teams to support timely and compliant clinical trial execution. - Assisting with the preparation, review, organization, and submission of regulatory documents for authorities and ethics committees. - Supporting clinical site qualification activities, including documentation collection and review to ensure compliance with ICH-GCP guidelines and applicable regulations. - Setting up, maintaining, and archiving study documentation within Trial Master Files (TMF) and Clinical Trial Management Systems (CTMS). - Maintaining essential study documents and ensuring files are complete, organized, inspection-ready, and available throughout the study lifecycle. - Supporting site identification activities, feasibility questionnaires, site selection processes, and trial start-up activities. - Assisting with the development and maintenance of clinical operations documents, logs, newsletters, and study materials. - Coordinating meetings with investigators, clients, vendors, and internal teams, including logistics and documentation support. - Managing shipment and tracking of trial materials, site documents, manuals, and required supplies. - Monitoring compliance metrics, tracking deadlines, and supporting follow-up activities with clinical teams. - Supporting the distribution and tracking of safety information, including SUSAR documentation and acknowledgements. - Downloading and organizing reports from clinical systems to support project managers and clinical trial managers. - Maintaining study portals, websites, newsletters, and other communication platforms. - Preparing progress reports, supporting invoice processing, and assisting with site payment coordination. - Following departmental procedures, supporting SOP updates, and contributing to inspection and audit readiness activities. - Providing general operational support to clinical teams and assisting with additional clinical operations activities as needed. ## Requirements: The ideal candidate is a detail-oriented professional with strong organizational skills and an interest in clinical research operations. Required qualifications and experience include: - Bachelor’s degree in Life Sciences or a related field. - Strong written and verbal communication skills with the ability to collaborate effectively with multiple stakeholders. - Excellent computer skills and advanced proficiency with Microsoft Office applications. - Minimum of 1 year of administrative support experience preferred. - Experience managing and maintaining electronic…