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

● Bachelor degree and above.

● 1-5 years CTA 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 as provided in company training.

● Knowledge of applicable protocol requirements as provided in company training.