Clinical Trial Assistant
Responsibilities:
Delivered comprehensive administrative support to the study team, ensuring the smooth operation of critical clinical research activities.
Meticulously organized and maintained vital clinical study documentation and guidelines, facilitating seamless access and adherence to critical study protocols.
Played a key role in ensuring the quality control of audits for clinical study documentation, contributing to the accuracy and compliance of study records.
Successfully maintained and updated Clinical Trial Management Systems, improving data accuracy and streamlining study management processes.
Tracked study training records and essential documents, ensuring compliance with regulatory standards and the readiness of study files.
Actively participated in crucial team meetings and meticulously recorded meeting minutes, enhancing transparency and accountability within the study team.
Maintained a high standard of accuracy and timeliness in filing all electronic Trial Master File (eTMF) documents, contributing to the organization and accessibility of critical study information.
Conducted periodic eTMF reviews to maintain inspection-ready study files at all times, ensuring compliance and preparedness for regulatory assessments.
Demonstrated proficiency in performing effective sampling and coherent quality control for PM, CTM, and CRA, ensuring data accuracy and reliability.".
Organized and maintained up-to-date study mailboxes, facilitating prompt access to critical study communications and documentation.