Clinical Trials Assistant

• 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.

Job Requirements:

• Bachelors Degree in Pharmaceutical or related field

• Min. 1 - 3 years of experience in clinical research environment

• Open to candidates from non-clinical research environment but strong experience in administrative duties

• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Broad knowledge of applicable protocol requirements as provided in company training

• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint

• Good 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

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