Job Description • 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. • 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. • 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. • Intake Call Notes: Bachelor’s degree required with 2 years relevant work exp, Will conduct phone screens first before onsite Additional Information All your information will be kept confidential according to EEO guidelines.