Lead Clinical Research Associate

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as their Lead Clinical Research Associate (LCRA). In this role, you will support study management tasks, collaborating with the Clinical Trial Manager and Director. A key responsibility is leading monitoring oversight activities for clinical CROs, ensuring protocol adherence, regulatory compliance, and timely completion of studies. You will create training materials, review monitoring reports, and develop performance metrics. The LCRA will also oversee site setup, assist with document review, participate in investigator meetings, and collaborate with CRO counterparts. International travel is required. This position requires a strong scientific background and extensive experience in clinical research.

Requirements

• BS/BA degree in a scientific discipline; advanced degree preferred
• Minimum of 3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical and/ or CRO company
• Highly organized, outcome oriented, self-motivated performance
• Ability to adapt to change in a growth 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

Responsibilities

• Serve as a representative of Scholar Rock to CRO, study vendors, and site staff
• Create CRA training materials and ensure the CRO CRAs are adequately trained and are prepared to train the study 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
• Develop and monitor metrics to evaluate the CRO CRAs and site performance and ensure compliance with ICH-GCP, SOPs, Local Laws & Regulations, Protocol, Monitoring Plan and associated documents
• Ensure the Trial Master File is maintained in an inspection-ready state at the CRO. Review for compliance and address findings as needed
• Oversee the setup activities and activation at the study sites
• Assist the Clinical Trial Manager in the review of ICFs and essential documents
• Participate in investigator meetings and assist with planning
• Collaborate with the CRO counterpart
• Travel, including international travel, required

Preferred Qualifications

Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable