The CPA will report to the Associate Director, Clinical Research and work with a team of CRA's on multiple projects in a high-paced work environment. The ideal candidate possesses a high level of organizational, interpersonal and communication skills and will have some experience working with clinical study documents that are contained within a typical clinical trial master file, as well as assist with ordering and shipping of clinical supplies to study centers.
Essential Duties and Job Functions: The position entails work under general supervision for routine tasks and with detailed instructions on new assignments. Primary responsibilities include: Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools. Processes drug shipments, drug returns, and assists with in-house drug reconciliation. Orders and maintains inventory of clinical supplies. Orders and ships case report forms. Assists with development of documents for site binders. Assembles and prepares distribution of site binders. Serves as CRA back up providing verbal and written communication with study personnel. Under close supervision reviews and participates in the quality assurance of data or documents. Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks. May assist with monitoring visits under the direct supervision of senior staff. Travel may be required.
Knowledge, Experience and Skills: Typically requires a BS or BA in a relevant scientific discipline or equivalent. Or requires an AS or AA (or European equivalent) degree plus 1 year relevant clinical experience for a clinical administrative support (non-career track) position. Excellent verbal and written communication skills and interpersonal skills are required. Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus. Must be able to work both independently and as part of a team.

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