Job Overview
Perform 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 02Req
● 3 years administrative support experience.
● r.
● 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