Clinical Research coordinator/ Clinical Project Associate

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.