Clinical Trial Assistant
Cambridge, MA
Development – Clinical Operations /
Full-Time /
Hybrid
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
