Clinical Research Administrative Assistant

Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery in conjunction with Clinical Research Associates and Regulatory and Start-Up teams.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF), to track site compliance and performance within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
• Conduct periodic reviews of study files for completeness.
• Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Track and manage 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.
• 3 years of administrative support 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.