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鈥檚 degree required with 2 years relevant work exp, Will conduct phone screens first before onsite