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.

Position 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
  • Assist in the planning, execution, and management of clinical trials from start-up to close-out.
  • TMF and file maintenance
  • Distributes, collects, and tracks large amounts of documentation accurately and within project timelines
  • Assist with inspection readiness activities
  • Assists with preparation of reports and technical or scientific publications, as required
  • Assists with other study and department related tasks as needed
  • Minimal Travel, including international travel, required (~15%)

Candidate 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