Job Description :
Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
Provide input and assist with harmonization of Clinical Operations databases and tracking tools. Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database (GILDA Processes re-supply drug shipments.
Order and maintain inventory of clinical supplies.
Order and ships case report forms.
Assists with development of documents for site binders.
Assembles and coordinates 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.
The position 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.
Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings.