Clinical Trials Assistant with Start Up responsibilities Sponsor-dedicated
Clinical Trials Assistant with Start Up responsibilities Sponsor-dedicated
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Job Description
Job Overview
Perform daily administrative activities in conjunction with the Clinical Research Associates and Regulatory and StartUp teams to ensure a complete and accurate Trial Master File delivery.
Essential Functions
Assist Clinical Research Associates (CRAs) and Regulatory and StartUp (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.
Experience in RA and EC Submissions
Experience in EUCTR
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
High School Diploma or equivalent Req
At least 2 year experience as CTA with Start Up responsibilities
Equivalent combination of education training and experience.
Minimum one year clinical research experience strongly preferred.
Computer skills including working knowledge of Microsoft Word Excel and PowerPoint.
Written and verbal communication skills including good command of Greek and 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.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Employment Type
Full-Time
