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Form of workScholar 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 (TGF) 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:
The In-House 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:
- 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 20% overnight travel
Candidate Requirements:
- 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.
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