Clinical Trial Assistant

This role represents a great opportunity to be a part of a growing clinical organization.  The Clinical Trial Assistant will support all administrative aspects of study management from start-up through closeout.     

Responsibilities

• Responsible for taking and distributing meeting minutes for both internal and external meetings, in the office and via teleconferences.
• Scheduling activities and setup virtual meetings, including compilation of materials and overseeing presentations
• Review study vendor meeting minutes and documents for accuracy.
• Filing and routing of agreements related to Clinical Operations.
• Preparing and tracking green light packets/ essential document packets for review.
• Creating and updating trackers for metric reporting
• TMF and file maintenance
• Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.
• Assists with preparation of reports and technical or scientific publications, as required.
• Minimal Travel, including international travel, required (~15%)

Requirements

• Bachelor’s Degree Preferred
• Experience in a CRO, Sponsor or clinical research administration function, including hands on experience relating to the essential documentation of a clinical trial.  Experience supporting Drug or Biologics trials strongly preferred.
• Excellent computer skills including knowledge of Excel, Word, PowerPoint, and Lotus notes. Database skills a requirement
• Good understanding of the policies and procedures of Clinical Operations and ICH-GCP, particularly relating to essential documentation
• Excellent time and priority management, able to work efficiently under pressure
• Excellent organizational and problem-solving skills
• Thrives in a fast-paced and evolving environment
• Self-motivated, shows initiative, is proactive and able to work on his/her own as well as in a team
• Good communication skills - both verbal and written
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact