Scholar Rock is a Phase 3, 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 now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. 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:
The Clinical Research Associate (CRA) will provide support for study management tasks in collaboration with the Lead CRA and Clinical Operations Team with an emphasis on monitoring oversight activities for our Clinical Research Organizations (CROs). The CRA works with clinical to assure that protocol requirements, laboratory collections, regulatory guidelines and timelines are met.
Serves as a representative of Scholar Rock to CRO, study vendors, and site staff
Review Monitoring Visit Reports from the CRO
Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed
Attend Qualification and Site Initiation visits
Track Metrics related to Sponsor Oversight and the Monitoring Plan
Lead the Trial Master File processes
Assist the Clinical Trial Manager in the review of ICFs and essential documents
Track clinical supply shipments and manage shipment logistics
Participate in Investigator Meeting planning
Collaborate with the CRO counterpart
Performs clinical oversight of study site management/monitoring activities in compliance with ICH-GCP, SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
Minimum 80% overnight travel, including international travel, required
BS/BA degree in a scientific discipline
Languages: Fluent in both written and spoken English
Minimum of 2-3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical and/ or CRO company