• 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

All your information will be kept confidential according to EEO guidelines.