Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) 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 accuracy and completeness.
Assist CTLs 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.
Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred
Knowledge of applicable protocol requirements as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Strong written and verbal communication skills including good command of English language
Effective time management and organizational skills
Attention to detail and accuracy in work
Ability to establish and maintain effective working relationships with coworkers, managers and clients
School diploma/certificate or equivalent combination of education, training and experience; BS/BA preferred.