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About the role
Key responsibilities & impact- Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems, including the 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.
Requirements
What you’ll need- Bachelor’s or higher-level degree preferable in life science.
- At least 1 year of experience as Clinical Trials Assistant.
- 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 Spanish.
- 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.