Clinical Research Associate
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: September 20, 2022
Company
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.
Position Responsibilities:
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- 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
Candidate Requirements:
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- 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
- Highly organized, outcome oriented, self-motivated performance
- Thrives in a fast-paced and evolving environment
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
- Strong written and oral communication skills
- Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.