Clinical Trials Assistant, Sponsor Dedicated

About the Role We are seeking a Clinical Trials Assistant to support the Sponsor Dedicated program in Seoul. This role works with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure a complete and accurate Trial Master File (TMF) and compliant clinical documentation.

What You'll Do

• Assist CRAs and RSU with updating and maintaining TMF and tracking site compliance within project timelines.
• Assist with the preparation, handling, distribution, filing, and archiving of clinical documents and reports according to scope of work and standard operating procedures.
• 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 accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• 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.

What We're Looking For

• A minimum of 1 year of experience in a CTA role is required.
• Strong communication skills in English (both spoken and written) are essential.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of 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. You are trained on data up to October 2023.