Clinical Trials Assistant-Sponsor Dedicated Team

Clinical Trial Administrator, Single Sponsor dedicated

Job Overview: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, and within the Local Study Team (LST) 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 good command of Romanian 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 requirement, 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.