Senior Clinical Trial Assistant

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as a Clinical Trial Assistant. This role supports all administrative aspects of study management, from start-up to closeout. You will be responsible for tasks such as taking and distributing meeting minutes, scheduling activities, reviewing documents, and maintaining files. The position requires experience in clinical research administration, excellent computer skills, and a strong understanding of clinical operations policies and procedures. This is a great opportunity to contribute to a growing clinical organization.

Requirements

• Possess experience in a CRO, Sponsor or clinical research administration function, including hands-on experience relating to the essential documentation of a clinical trial
• Have excellent computer skills including knowledge of Excel, Word, PowerPoint, and Lotus notes. Database skills are a requirement
• Demonstrate a good understanding of the policies and procedures of Clinical Operations and ICH-GCP, particularly relating to essential documentation
• Possess excellent time and priority management skills and be able to work efficiently under pressure
• Possess excellent organizational and problem-solving skills
• Thrive in a fast-paced and evolving environment
• Be self-motivated, show initiative, be proactive and able to work independently as well as in a team
• Have good communication skills - both verbal and written
• Have good interpersonal skills and the ability to deal with people at all levels with sensitivity and tact

Responsibilities

• Take and distribute meeting minutes for both internal and external meetings, in the office and via teleconferences
• Schedule activities and setup virtual meetings, including compilation of materials and overseeing presentations
• Review study vendor meeting minutes and documents for accuracy
• File and route agreements related to Clinical Operations
• Prepare and track green light packets/essential document packets for review
• Create and update trackers for metric reporting
• Maintain TMF and files
• Distribute, collect, and track large amounts of documentation accurately and within project timelines
• Assist with inspection readiness activities
• Assist with preparation of reports and technical or scientific publications, as required
• Assist with other study and department related tasks as needed

Preferred Qualifications

• Possess a Bachelor’s Degree
• Have experience supporting Drug or Biologics trials