Clinical Trial Assistant

2 weeks ago

ontario, Canada Nexcella, Inc. Full time

Clinical Trial Assistant (Cell Therapy)Greater Toronto Area / HybridGreater Montreal Area / HybridOur 3 Core Values • Intelligence• Integrity• Initiative Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting What You'll Do• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.What We Look For• Bachelors degree or equivalent• Administrative support experience.• Equivalent combination of education, training and experience.• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.• Written and verbal communication skills - must be fluent in both English and local language• Effective time management and organizational skills.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.• Knowledge of applicable protocol requirements as provided in company training.About Nexcella Nexcella Inc., a wholly-owned Immix Biopharma subsidiary, is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.Learn more at www.nexcella.com

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