Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are planning to advance to a Phase 3 trial by year-end. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
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.
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%)
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.