CLINICAL TRIALS ASSISTANT, CFSP

Job Overview   Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF).
Essential Functions Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.
., TMF) to track site compliance and performance within project timelines.
Support 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.
Conduct periodic reviews of study files for completeness.
Help CRAs and RSU with the preparation, handling, and distribution of Clinical Trial Supplies and maintain tracking information.
Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
Serve 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 Life science degree Minimum of 3 years of administrative support experience.
Study Coordinator or CTA related experience is highly valued Equivalent combination of education, training, and experience will be considered.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Excellent written and verbal communication skills, with a strong command of the 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, including 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.
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We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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