Clinical Trial Assistant

About this role

Responsibilities

• Establishes, maintains, and updates various databases for clinical tracking
• Maintains clinical operations files and version control
• Responsible for ordering and shipping supplies in coordination with all phases of the clinical studies, maintains files and inventories of supplies and equipment
• Tracks and reviews incoming and outgoing clinical and regulatory documents and updates
• Ensures proper drug shipments and returns and assists with in-house reconciliation
• Processes, logs and distributes completed case report forms
• In-house verification of electronic case report forms, queries and clinical data flow
• Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Assists with tracking and reviewing clinical trial budgets and invoices
• Participate in team meetings and assist in preparation of agendas, minutes, and tracking of action items
• Follows standard operating procedures
• Travel may be required up to 5% of the time

About you

Requirements

• Ability Bachelor’s Degree or equivalent in health sciences
• 2 years in support of clinical research project teams for a CRO or pharmaceutical/biotech company
• Working knowledge of regulatory requirements (FDA, ICH) including Good Clinical Practice principles and industry standards
• Demonstrated experience working with management teams and third party contractors
• Ability to multitask with significant attention to detail and to manage shifting priorities associated with an early stage drug development company
• Strong database skills
• Effective time management and organization skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Strong written and verbal communication skills
• Proficient in the use of MS Word, Excel, PowerPoint and Project

What we offer

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