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. 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.
● 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 02Req
● 3-4 years administrative support experience.
● r 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 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.