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Form of workJob Description
Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory teams , to ensure a complete and accurate delivery.
Essential Functions
" Assist Clinical Research Associates (CRAs) and Regulatory team with accurately updating and maintaining clinical documents and systems 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 Regulatory team 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
" Bachelor's Degree Required
" 2 years administrative support experience.
" 2 years Clinical Trial Experience
" ETMF 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.
" Knowledge of applicable protocol requirements
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
