Clinical Project Associate

Clinical Project Associate

Project involvement will be in an administrative role. Provides administrative support to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File (including RDMS) for studies on an as needed basis. The position entails work under general supervision for routine tasks and with detailed instructions on new assignments. Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.

Distributes updated study related documents to study teams and internal departments as requested by the CTMA or CTM. Under close supervision reviews and participates in the quality assurance of data or documents including and not limited to GILDA and Data Vision. Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes. Interacts with other departments, as directed, to complete assigned tasks.

Typically requires a BS or BA in a relevant scientific discipline. 2+ years of experience and an Associate's degree. Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.

Excellent verbal and written communication skills and interpersonal skills are required. Must be able to work both independently and as part of a team.