Sr. Clinical Trial Assistant

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.  Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
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

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.