Project Management Specialist – Optimized Trials

Responsibilities

• Support the successful performance and operations of Elligo’s clinical trials.
• Serve as a liaison between multiple departments to ensure project tasks are tracked and/or completed.
• Coordinate collection and submission of all regulatory related documents.
• Obtain and review required medical records, data entry, and other various project support tasks.
• Perform set-up, maintenance and close out project files and study information.
• Works within forecasted submission/approval timelines and tracks milestone progress.
• Prepare and complete the preparation of regulatory documents required for IRB/IBC approvals.
• Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes.

Requirements

• BS/BA in Life Science or related discipline.
• Minimum of one (1) year clinical research experience (including Study Coordinator, CRO experience) or working in a healthcare setting.
• Previous GCP training and certification is preferred.
• Experience working with electronic medical records (EMRs); electronic health record system proficiency is preferred.
• Data entry experience is preferred.