RESPONSIBILITIES MIGHT INCLUDE : Assist Clinical Research Associates (CRAs) and Regulatory-Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
Assist the clinical team in 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 with finance activities related to invoices, payment handling.
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 and with required approval.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of applicable protocol requirements as provided in company training Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint Fluent written and verbal communication skills in Dutch and in French, 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