Clinical Trials Assistant 1

Job OverviewPerform 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**:- High School Diploma or equivalent.- 3 years administrative support experience.- Equivalent combination of education, training and 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.- 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.