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Job Overview
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.
Essential Functions
● Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., 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.
Qualifications
● Life science related bachelor’s degree or above
● 1 year + CTA experience.
● Good at communication, quick learner.
● Familiar with VBA or other automation technical skills (such as Power Apps, Power Automate, Python, etc.), proficient in using Excel, especially formula application will be given priority consideration.
● 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.
● 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