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Clinical Trial Assistant- Sponsor Dedicated
Responder al anuncioClinical Trial Administrator, Single Sponsor dedicated
Job Overview:
The Clinical Trial Administrator (CTA) performs 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.
By assisting in the coordination and administration of the study activities from the start-up to execution and close-out, the Clinical Trial Assistant ensures quality and consistency of study deliverables to time, cost, and quality objectives.
Essential Functions:
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems like Trial Master File 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.
- Coordinate 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 collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Qualifications:
- High School or University Diploma.
- Clinical research administrative support experience preferred.
- Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint.
- Written and verbal communication skills including a good command of Spanish and English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Basic knowledge 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.
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