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. 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.
Qualifications
● bachelor degree and above.
● 1-3 years clinical research support experience.
● 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.